Below is a list of current Centre for Food & Allergy Research randomised controlled trials to evaluate novel treatment or prevention strategies for food allergy.  Click each study title to expand for more information.

This study tests whether eating egg for the first time at a younger age (i.e. six months instead of 10 months) may help prevent egg allergy.

In Australia, egg allergy is the most common food allergy in children under five. Until recently, it has been common practice to delay the introduction of egg into the diets of babies until around 12 months of age. However recent studies suggest that introducing egg earlier (at around four to six months) may reduce the risk of developing an egg allergy.

STEP compares the presence of egg allergy in babies who first ate egg between four and six months with babies who first ate egg at ten months. All mothers of the babies in STEP had a history of allergic disease (e.g. eczema, asthma or hay fever plus aeroallergen sensitisation).

Contact: [email protected] (Adelaide, SA) or [email protected] (Perth, WA)

Study design Double-blind randomised controlled trial
Investigators Maria Makrides, Susan Prescott, Debbie Palmer, Mike Gold
Time frame 2010-15
Funding source National Health and Medical Research Council (grant 626805)
Location Adelaide and Perth, Australia
Sample 1194 infants at high risk of allergic disease
Aims Primary aim:

  • Determine whether early, regular exposure to egg (from four to six months) reduces the risk of egg allergy at 12 months

Secondary aims:

  • Compare the effect of regularly eating egg after four to six months with eating egg for the first time at ten months on:
  • Eczema severity (SCORAD)
  • Sensitisation to egg (positive egg SPT)
  • Sensitisation to other allergenic foods or aeroallergens
  • Egg specific IgE and IgG4
  • IgE- mediated food allergy (other than egg) defined as an allergic reaction to the food (from history) and sensitisation to that food
Methods Infants of mothers with a history of allergic disease (atopic dermatitis/eczema, asthma or hayfever, plus sensitisation to one or more common aeroallergen) were recruited from postnatal wards at maternity hospitals (Adelaide, SA) or from antenatal clinics at maternity hospitals (Perth, WA) and assigned to receive daily until 10 months old a dose of powder containing either:

  • egg, carrot and pineapple powder (intervention group), or
  • rice, carrot and pineapple powder (control group)

Infants were then assessed for egg allergy at 12 months of age.

Data collected
  • Parental questionnaire about infant feeding, food reaction history and allergy symptoms
  • Skin prick test
  • Oral food challenge (pasteurised raw egg)
  • Eczema (examination, SCORAD)
  • Blood sample (egg specific IgE, IgG4, immunological markers)
  • Stool sample (Perth participants) (gut microflora)
Primary outcome Diagnosis of IgE-mediated egg allergy at 12 months of age, defined as an allergic reaction to the oral egg challenge and sensitisation to egg.

This trial tests whether a treatment plan involving both probiotics and peanut oral immunotherapy (PPOIT) can help build a tolerance to peanuts in children who are allergic to them.

As there is no cure for food allergy, ‘treatment’ usually consists of avoiding foods you are allergic to and knowing how to recognise and manage allergic reactions. A peanut allergy can be especially difficult to manage because it causes more life-threatening reactions (called anaphylaxis) than other food allergies and doesn’t usually resolve like other food allergies commonly do.

PPOIT compares the rate of resolution of peanut allergy in children who received the combined PPOIT treatment for 18 months with those children who received a placebo for the same length of time.

Contact: [email protected]

Study design Double blind placebo controlled randomised controlled trial
Investigators Mimi Tang, Anne-Louise Ponsonby, Susan Donath, Wesley Burks
Time frame Study completed 2013; follow up is ongoing
Funding source National Health and Medical Research Council (grant 1029690), US Food Allergy and Anaphylaxis Network, Murdoch Childrens Research Institute, Perpetual Philanthropy, The Contributing to Australian Scholarship and Science (CASS) Foundation, Financial Markets Foundation for Children;
Location Melbourne, Australia
Sample 62 peanut-allergic children between one and ten years of old
Aims Examine whether treatment involving both probiotics and peanut oral immunotherapy can lead to:

  • Peanut tolerance (the ability to eat more than four grams of peanut protein in an oral peanut challenge 2-12 weeks after treatment stops without reacting)
  • Peanut desensitisation (the ability to eat more than two grams of peanut protein in an oral food challenge performed on the last day of treatment without reacting)
  • Examine the effects of this treatment on:
  • Serum levels of peanut specific IgE and peanut specific IgG4 
  • Peripheral blood T regulatory cell and dendritic cell populations and T helper 1 and T helper 2 cytokine production
Methods Children with a diagnosed peanut allergy were recruited from the Department of Allergy and Immunology, The Royal Children’s Hospital, Melbourne and from the community; and randomly assigned to receive one of two treatments for 18 months:

  • Combined probiotic and peanut oral immunotherapy (intervention group), or
  • Maltodextrin/maltodextrin (control group)
  • Peanut allergy was assessed between two and six weeks after finishing treatment.
Data collected
  • Parental questionnaire about child’s quality of life
  • Oral food challenge
  • Blood sample (peanut specific IgE, IgG4, immunological markers)
  • Stool sample (microbiota studies)
  • Saliva sample (peanut specific IgA)
Primary outcome Tolerance acquisition (resolution of peanut allergy) at the end of 18 months.
(Tolerance defined as the ability to eat more than four grams of peanut protein without reacting in an oral peanut challenge after discontinuation of treatment for more than 2 weeks)

This trial tests whether a treatment plan involving both probiotics and peanut oral immunotherapy (PPOIT) can help build a tolerance to peanuts in children who are allergic to them.

As there is no cure for food allergy, ‘treatment’ usually consists of avoiding foods you are allergic to and knowing how to recognise and manage allergic reactions. A peanut allergy can be especially difficult to manage because it causes more life-threatening reactions (called anaphylaxis) than other food allergies and doesn’t usually resolve like other food allergies commonly do.

PPOIT compares the rate of resolution of peanut allergy in children who received the combined PPOIT treatment for 18 months with those children who received a placebo for the same length of time.

Contact: [email protected]

Study design Double blind placebo controlled randomised controlled trial
Investigators Mimi Tang, Anne-Louise Ponsonby, Susan Donath, Wesley Burks
Time frame Study completed 2013; follow up is ongoing
Funding source National Health and Medical Research Council (grant 1029690), US Food Allergy and Anaphylaxis Network, Murdoch Childrens Research Institute, Perpetual Philanthropy, The Contributing to Australian Scholarship and Science (CASS) Foundation, Financial Markets Foundation for Children;
Location Melbourne, Australia
Sample 62 peanut-allergic children between one and ten years of old
Aims Examine whether treatment involving both probiotics and peanut oral immunotherapy can lead to:

  • Peanut tolerance (the ability to eat more than four grams of peanut protein in an oral peanut challenge 2-12 weeks after treatment stops without reacting)
  • Peanut desensitisation (the ability to eat more than two grams of peanut protein in an oral food challenge performed on the last day of treatment without reacting)
  • Examine the effects of this treatment on:
  • Serum levels of peanut specific IgE and peanut specific IgG4 
  • Peripheral blood T regulatory cell and dendritic cell populations and T helper 1 and T helper 2 cytokine production
Methods Children with a diagnosed peanut allergy were recruited from the Department of Allergy and Immunology, The Royal Children’s Hospital, Melbourne and from the community; and randomly assigned to receive one of two treatments for 18 months:

  • Combined probiotic and peanut oral immunotherapy (intervention group), or
  • Maltodextrin/maltodextrin (control group)
  • Peanut allergy was assessed between two and six weeks after finishing treatment.
Data collected
  • Parental questionnaire about child’s quality of life
  • Oral food challenge
  • Blood sample (peanut specific IgE, IgG4, immunological markers)
  • Stool sample (microbiota studies)
  • Saliva sample (peanut specific IgA)
Primary outcome Tolerance acquisition (resolution of peanut allergy) at the end of 18 months.
(Tolerance defined as the ability to eat more than four grams of peanut protein without reacting in an oral peanut challenge after discontinuation of treatment for more than 2 weeks)

This trial tests whether eating egg for the first time at a younger age (i.e. between four and six months of age) can help prevent egg allergy in babies at high risk of allergic disease.

For many years, doctors and researchers believed that giving common allergens (such as egg, wheat, nuts and fish) to babies too early could cause food allergies – especially where a parent or sibling already had an allergy. As a result, many families avoided eating these foods and yet the number of children with food allergies has only increased over the last two decades. This has led researchers to re-think the relationship between early exposure to common food allergens and the development of food allergies.

BEAT compares the presence of egg allergy in children who ate foods mixed with egg powder each day for four to eight months with children who ate foods only mixed with rice powder. Only children who were not allergic to eggs by four to six months of age could participate in the trial. All participating children avoided other forms of egg during the trial and were assessed for allergic disease at eight and 12 months of age.

Contact: [email protected]

Study design Double blind placebo controlled randomised controlled trial
Investigators Dianne Campbell, Alyson Kakakios, Preeti Joshi, Sam Mehr, Paul Turner, Melanie Wong
Time frame 2009 – 2014
Funding source Ilhan Food Allergy Foundation
Location Sydney, Australia
Sample 300 infants with family history of allergic disease
Aims Primary aim:

    • Determine if introducing egg between four and six months reduces the risk of egg allergy at eight and 12 months

Secondary aims:

  • Determine if introducing egg between four and six months reduces the risk of eczema during the first year of life
  • Assess laboratory markers of tolerance/sensitisation to egg proteins (ovalbumin and ovomucoid)
Methods Babies with at least one parent or sibling with an allergic disease were recruited at birth (i.e. food allergy, eczema, asthma or hay fever) and then were assessed for egg allergy at four months of age and if they were not sensitised to egg, were assigned to receive a daily dose of powder containing either:

  • freeze dried egg powder (intervention group), or
  • rice powder (control group)
  • Infants were assessed for egg allergy at eight and 12 months of age. At each stage, any infant skin prick test positive to egg was referred to an Allergist at a hospital-based allergy clinic for oral food challenge.
Data collected
  • Parental questionnaire about maternal smoking, family size, birth order and family history of allergic disease.
  • Skin prick test
  • Oral food challenge
  • Blood sample (ovalbumin and ovomucoid IgE, IgG1 and IgG4, Tregulatory cell phenotype)
  • Dietary assessment
Primary outcome Egg allergy at 12 months of age (Oral food challenge)

This trial will test whether the number of eggs a woman eats during the early weeks of breastfeeding affects the amount of egg protein in her breast milk.

Recent studies have found that a number of infants are now reacting (and sometime quite severely) to eggs the very first time they eat them. Since our immune systems need to have experienced an allergen (i.e. egg) at least once before they develop an allergic response, this suggests that some babies are becoming sensitised to egg before they have had a chance to eat it themselves. This means that prevention strategies may need to happen even earlier than previously thought.
QuEST will collect blood and breast milk samples from participating women during their first six weeks of breastfeeding. It will compare the levels of egg protein in breast milk between women who eat four to six eggs a week, one to three eggs per week or no eggs at all during this six-week period. All the women in QuEST have an allergic disease (i.e. asthma, eczema, hay fever and/or food allergy).

Contact: [email protected]

Study design Randomised controlled trial
Investigators Debbie Palmer, Susan Prescott
Time frame 2013-15
Funding source Princess Margaret Hospital Foundation; National Health and Medical Research Council (1046036)
Location Perth, Australia
Sample 120 women with an allergic disease
Aims Primary aim:

  • Investigate the effect of maternal dietary egg intake on levels of egg proteins (ovalbumin and ovomucoid) in breast milk

Secondary aims:

  • Investigate the effect of maternal dietary egg intake on
  • levels of egg proteins (ovalbumin and ovomucoid) in mother and infant serum
  • variations in maternal and infant skin integrity
  • infant eczema and sensitisation to egg at three to four months of age (before solid food containing egg have been included in the infant’s diet)
Methods Women with an allergic disease (i.e. asthma, eczema, hay fever and/or food allergy) are randomly allocated to follow one of three diets for six weeks after giving birth:

  • four to six eggs per week (high egg diet)
  • one to three eggs per week (low egg diet)
  • No eggs (egg-free diet)

Levels of egg proteins in blood and breast milk are measured at two, four and six weeks after giving birth.

Data collected
  • Parental questionnaire about infant feeding and allergy symptoms
  • Breast milk sample (egg protein levels – ovalbumin and ovomucoid)
  • Blood sample from mother and infant (egg protein levels – ovalbumin and ovomucoid, egg specific IgE)
  • Eczema (examination, SCORAD, TEWL)
Primary outcome Breast milk ovalbumin and ovomucoid (egg proteins) levels at two, four and six weeks of lactation.

This trial tests what impact a vitamin D supplement given in the first six months of life has on the immune system of children with a family history of allergic disease.

While rates of vitamin D insufficiency have been increasing, so too has the evidence that vitamin D plays an important role in the health of our immune systems. This means there is a strong need to better understand the exact relationship between vitamin D and allergic diseases such as food allergy. VITAL will compare the immune responses and vitamin D levels of children who receive a vitamin D supplement in the first six months of life with those who do not.

Contact: [email protected]

Study design Double blind randomised controlled trial
Investigators Debbie Palmer, Susan Prescott, Aris Siafarikas, Kristina Rueter, Ee Mun Lim
Time frame 2013-15
Funding source Asthma Foundation Western Australia; Telethon-New Children’s Hospital Research Fund
Location Perth, Australia
Sample 120 infants with a family history of allergic disease
Aims Primary aim:

  • Determine the effect of infant vitamin D supplementation during the early postnatal period on immune system development

Secondary aims:

  • Determine the effect of infant vitamin D supplementation during the early postnatal period on Vitamin D levels at three, six and 12 months of age Bone metabolism at three, six and 12 months of age (calcium, phosphate, alkaline phosphatase) Gut microflora colonisation patterns at six months of age Allergic disease (eczema and/or food allergy) at six and 12 months of age Sensitisation to food and aeroallergens at 12 months of age
Methods Mothers are recruited from antenatal clinics and classes at private and public hospitals in Perth. Infants have a parent and/or sibling with an allergic disease (asthma, eczema, hay fever, food allergy) and enrolled into the study prior to one month of age. To be eligible, their mothers need to have a normal vitamin D level during late pregnancy. Infants were randomly assigned to receive a daily drop (0.03mL) of liquid containing either:

  • 400IU of vitamin D3-Cholecalciferol, contained within coconut and palm kernel oil (intervention group), or
  • Coconut and palm kernel oil only (control group)

Vitamin D status is assessed at three, six and 12 months of age and immune responses are assessed at six months of age.

Data collected
  • Parental questionnaire about infant feeding, sun exposure, allergy symptoms
  • Skin prick test
  • Eczema (examination, SCORAD)
  • Blood sample (vitamin D, calcium, phosphate, alkaline phosphatase, IgE, immunological markers)
  • Stool sample (gut microflora)
Primary outcome Immune responses (to allergens, vaccines) at six months of age

This trial tests whether eating baked egg regularly helps children who are allergic to raw egg to ‘outgrow’ or build up a tolerance to it. 

If a child is allergic to egg, the standard practice is to recommend they avoid eating egg completely. However, many children with egg allergy eat baked egg (such as in a cake or biscuit) without reacting. This suggests that certain kinds of exposure to egg may lead the immune system to become more tolerant of that food.

CAKE compares the presence of raw egg allergy in children who have eaten baked egg two to three times a week for six months with children who completely avoided egg during this time. All children had a raw egg allergy at the start of the trial. Researchers wanted to see if eating baked egg helped children to ‘outgrow’ their egg allergy.

Contact: [email protected]

Study design Randomised controlled trial
Investigators Merryn Netting, Maria Makrides, Michael Gold, Imme Penttilla, Patrick Quinn
Time frame 2012-2014
Funding source Women’s and Children’s Hospital (WCH) Foundation, Ilhan Food Allergy Foundation, Australian Egg Corporation Ltd (AECL).
Location Adelaide, Australia
Sample 110 children with a raw egg allergy, aged six months to five years
Aims Primary aim:

  • Determine whether allergy to raw egg is better resolved by regular consumption of baked egg compared with the standard practice of an egg free diet.

Secondary aims:

  • Examine the effect of regular baked egg exposure on immunity, particularly on patterns of evolving allergen-specific responses and the induction of immune regulatory pathways that may play a role in tolerance induction.
  • Compare episodes of reactions due to accidental exposure between the groups consuming baked egg and those avoiding egg.
Methods Children are recruited from an Allergy clinic and self-referred via a media campaign. Prior to enrolment in the study, children undergo Skin Prick Testing and an Oral Food Challenge to Egg in Baked Goods. Children that can tolerate egg in baked goods are assigned to receive either:

  • baked goods containing egg (intervention group), or 
  • baked goods that are egg-free (control group)

Participating families then feed their child one serve or these baked goods two to three times a week for six months. At the end of this period, the children are given an oral food challenge for pasteurised raw egg.

Data collected
  • Oral food challenge (egg in baked goods and pasteurised raw egg)
  • Skin prick test
  • Blood sample (IgE, IgG4 and immunological markers)
  • Eczema (examination, SCORAD)
  • Height and weight
Primary outcome Resolution of raw egg allergy in children eating baked egg. Raw egg allergy assessed by an oral food challenge to pasteurised raw whole egg.

This trial tests whether avoiding cow’s milk, eggs, wheat and soy is an effective treatment for children with eosinophilic oesophagitis (EoE) – a condition where the tube connecting the mouth and stomach becomes swollen and painful.

As a newly recognised medical condition, very little is known about the best way to treat or manage eosiniphilic oesophagitis (EoE). At the moment, most children with EoE are told to avoid eating certain foods and to swallow a special type of steroid medication. However, because it can be difficult to make meals without these ingredients, families often stop following the food plan and their child’s EoE can become worse. For this reason, it is important we identify a food plan that is both effective and easy for families to follow.

4-FEED compares the presence of EoE in children who did not eat cow’s milk, egg, wheat or soy for 8-12 weeks with those who ate what they would normally. All participating children had recently been diagnosed with EoE and took omeprazole – a medication commonly used to treat reflux disease, to ensure that any changes were not due to reflux disease.

Contact:  [email protected]

Study design Randomised controlled trial
Investigators Ralf Heine, Katie Allen, Andrew Giraud, Geoffrey Davidson, Bircan Erbas
Time frame 2012-14
Funding source National Health and Medical Research Council (grant 1029972)
Location Melbourne, Sydney, Adelaide and Brisbane, Australia
Sample 118 children aged 1-18 years who had recently been diagnosed but not yet treated for EOE
Aims Primary Aim:

  • Determine if the elimination of the four most common food allergens (cow’s milk, egg, wheat, soy) will induce disease remission in children with EoE

Secondary aim:

  • Conduct mechanistic investigations of the regulation of inflammatory and mucosal remodelling changes (including interleukin (IL)-33)
Methods Children with 20 or more eosinophils per high power field (HPF) (on oesophageal histology) were recruited from paediatric gastroenterology units. Children with confirmed EoE were randomly allocated to follow one of two diets:

  • The four-food elimination diet (intervention group), or 
  • Their regular diet (control group

All children took omeprazole twice daily for the duration of the trial (8-12 weeks). A gastroscopy and oesophageal biopsies were conducted at the end of the study period to determine EOE status.

Data collected
  • Parental questionnaire about demographic information, their child’s food diary and symptom card
  • Gastroscopy
  • Oesophageal biopsies (upper gastrointestinal and two lower oesophageal)
  • Blood sample (IL-33 and related serum effector molecules)
Primary outcome Resolution of EoE based on oesophageal histology at 8-12 week follow-up. Remission defined as a mucosal eosinophil count <5 eosinophils/HPF.

This trial tests whether taking fish oil capsules high in omega 3 during pregnancy helps protect babies from developing an allergic disease. 

At the same time as rates of allergic disease have increased, the typical Australian diet has substantially changed and now includes more omega 6 fatty acids and less omega 3 fatty acids. Researchers are now examining whether particular fatty acids play an important role in the development of IgE mediated diseases such as food allergy.

DOMInO compares the presence of allergic disease in children whose mothers took fish oil capsules daily during pregnancy with children whose mothers took vegetable oil capsules instead. All the children in the allergy follow up of the DOMInO Trial had at least one parent or sibling with an allergic disease (i.e. eczema, asthma, hay fever).

Contact: [email protected]

Study design Double blind randomised controlled trial
Investigators Maria Makrides, Michael Gold, Debra Palmer, Susan Prescott
Time frame 2006-14
Funding source NHMRC (399389, 1027710)
Location Adelaide, Australia
Sample 706 infants with a family history of allergic disease.
Aims
  • Determine the effect of fish oil (n-3 LCPUFA) supplementation during pregnancy on the prevention of IgE-mediated allergic disease (i.e. food allergy, eczema, asthma and/or hay fever) at one, three and six years of age.
Methods This trial is part of a larger trial investigating the connection between n-3 LCPUFA supplementation during pregnancy and maternal depression and neurodevelopment in young children.Between 18 and 21 weeks into their pregnancy, participating women began taking three capsules daily of either:

  • fish oil concentrate (n-3 LCPUFA) (intervention group), or 
  • vegetable oil (without n-3 LCPUFA) (control group)

Children with a family history of allergic disease (asthma, hay fever, eczema) whose mothers were enrolled in the DOMInO Trial were then enrolled in the allergy follow-up study. They were tested for allergic disease and allergen sensitisation at one, three and six years of age.

Data collected
  • Parental questionnaire about infant feeding, the home environment, allergy symptoms, general health and hospitalisations
  • Skin prick testing
  • Clinical assessment of eczema, food allergy, asthma, allergic rhinitis (assessed by study doctors)
Primary outcome Diagnosis of allergic disease (eczema, food allergy, asthma or allergic rhinitis) with associated sensitisation to food or aeroallergens at one, three and six years of age.

PEBBLES is a randomised control trial to prevent the development of eczema and asthma in children. The study investigates whether a daily application of a ceramide dominant emollient can improve infant skin barrier function and further reduce the risk of eczema and asthma when compared to standard skin management.

Allergic diseases are common, with eczema affecting approximately 1 in 3 Australian infants while food allergy affects 1 in 10 infants. Allergic disease often start very early in life, and are associated with allergic sensitisation. There are currently no proven strategies to prevent children developing these conditions. Our work has shown children with eczema are at increased risk of development of food allergies and asthma. It is suspected infants become sensitised through the skin due to poor skin barrier function in early life. There is new evidence, including from our own pilot study, that regular application of emollients to an infant’s skin may prevent them from developing eczema. This is possibly because impaired skin barrier caused by eczema allows substances from the environment (allergens) to be exposed to the immune system through the damaged skin, resulting in allergic sensitization. Eczema may be the first step in the development of other allergies, so preventing eczema may also help reduce risk of other allergic diseases.

In this trial, researchers aim to test if daily application of EpiCeram™, a novel skin barrier repair emollient, to the skin of babies for six months can reduce the risk that they develop eczema and improve skin barrier function compared to standard skin management? Mother/baby pairs will be randomised to either the intervention group (daily EpiCeram™) or to the control group (standard skin care) for six months.

Study design Randomised controlled trial
Investigators Adrian Lowe, Mimi Tang, Shyamali Dharmage, John Su, Katie Allen, Michael Abramson, Lyle Gurrin and J Hui.
Time frame Intended commencement: early 2016.
Funding source Australasian College of Dermatologists; Financial Markets Foundation for Children; Victorian Asthma Foundation.
Location Melbourne, Australia
Sample 760 infants with a family history of allergic diseases
Aims Primary Aim:

  • To determine if routine application of an emollient to the skin of infants in early life prevents the development of eczema and food allergy.

Secondary aim:

  • To determine if this form of intervention is effective in children with a genetic predisposition (filaggrin null mutation) for having a poor skin barrier and increased risk of developing eczema.
Methods In this world first study, we will randomise 760 children with a family history of allergic disease to either receive:

  • Twice daily application of EpiCeram, a novel skin barrier repair treatment (intervention group) , or
  • Standard skin care (control group) to test if building the infant skin barrier in the first six months of life can reduce a) the true incidence of eczema, not only during the treatment period, but also in the six months after treatment cessation b) the development of food allergy and allergic sensitisation.

Primary outcomes will be assessed by a blind assessor. If successful, this trial will have wide spread implications for infant care, as well as reducing the burden of allergic diseases in our community.

This trial examines whether vitamin D supplementation given in the first 12 months of life can prevent the development of food allergy and reduce lower respiratory infections.

Postnatal vitamin D supplementation may be associated with important public health benefits, including a reduction in IgE-mediated food allergy, lower respiratory tract infections and improved bone health. In this context most countries in the Northern hemisphere have now recommended universal infant vitamin D supplementation to optimise early vitamin D levels. However, this is despite the absence of large scale trials proving either safety or efficacy for any disease or clinical outcome. Vitality will compare infants who receive vitamin D with infants receiving a placebo during the first 12 months of life. Vitality is the first large scale trial of postnatal vitamin D supplementation for infants.

Contact: [email protected]

Study design Double blind randomised controlled trial
Investigators Prof Katie Allen, Prof Anne-Louise Ponsonby, Prof Nigel Curtis, A/Prof Peter Vuillermin, Prof Shyamali Dharmage, A/Prof Lyle Gurrin, Dr Natalie Carvalho, Dr Jennifer Koplin
Time frame 2014-19
Funding source The Isabel & John Gilbertson Charitable Trust NHMRC application 2015
Location Melbourne, Australia
Sample 3012 healthy, breastfed 6-8 week old infants
Aims Primary Aim:

  • To determine if vitamin D supplementation reduces challenge-proven food allergy at 12 months of age

Secondary aim:

To determine if vitamin D supplementation reduces:

  • number of lower respiratory infections by 12 months of age
  • food sensitisation (positive skin prick test) at 12 months of age
  • moderately-severe and persistent eczema at 12 months of age
  • vitamin D deficiency at 12 months of age
Methods Infants are recruited from council-run immunisation sessions To be eligible, infants must be healthy, term, breastfeeding and 6-8 week old. Infants of mothers who intend to continue predominantly breastfeeding until 6-months will be recruited since formula feeding is a surrogate form of partial vitamin D supplementation.

  • 400IU of vitamin D3-Cholecalciferol, contained within coconut and palm kernel oil (intervention group), or
  • Coconut and palm kernel oil only (control group)
Data collected Parental questionnaire about infant feeding, sun exposure, allergy symptoms, demographics at baseline, 6, 9 and 12 months
Skin prick test
Oral food challenge
Eczema (examination, SCORAD)
Blood sample (vitamin D, calcium, phosphate, alkaline phosphatase, IgE, immunological markers)
Primary outcome challenge-proven food allergy at 12 months of age

This study investigates the allergens in fish consumed in Australia on biomolecular level, leading to improved diagnostic methods and better management for children with fish allergy in Australia and the Asia-Pacific region.

Allergy to fish among Australian children is emerging as a significant healthcare issue with approximately 1-3% prevalence. Moreover, one in four fish allergic children have severe clinical reactions (anaphylaxis). Despite this, there are significant restrictions on the ability to adequately diagnose and manage this life threatening disease in Australia. This is because allergens in Asian-Pacific fish have not been characterised. Therefore commercially available diagnostic tests are based on fish species from the Northern Hemisphere, which differ considerable to Asian-Pacific fish species. This study aims to improve the diagnosis and management of fish allergic children in Australia by identifying novel, clinically relevant allergens from commonly ingested Asian-Pacific fish species. This study will provide much-needed characterisation of allergens and improved diagnostic capacity by the development of novel in vitro and in vivo fish allergy tests. These advances will provide for increased diagnostic capacity and will lead to greater patient safety with an added potential for dietary liberalisation in fish allergic individuals.

Contact: [email protected], [email protected]


Study design Biomolecular characterisation of fish allergens and development of better diagnostics
Investigators Prof Andreas Lopata, Prof Dianne Campbell, Dr Sam Mehr, Prof Norelle Daly, Prof Katrina Allen, Dr Aya Taki, Mr Thimo Ruethers
Time frame 2015-18
Funding source NHMRC project grant
Location
Townsville (James Cook University), and Sydney (Children’s Hospital at Westmead), Australia
Sample Muscle tissue from >60 Asian-Pacific fish species;

Blood samples from 200 fish allergic children

Aims Identification and characterisation of fish allergens for improved diagnosis in Australian children

  • Identify and characterise a cohort of children with IgE mediated fish allergy
  • Characterise the major fish allergens in bony- and cartilaginous fish from Australia and the Asia-Pacific region
  • Characterise the B-cell epitopes of major fish allergens

Develop novel fish allergy diagnostics and validate by challenge proven fish allergy and tolerance

Methods
  • Skin Prick Testing
  • Immune-diagnostics
  • Immunoblotting
  • ELISA
  • Mass spectrometry
  • Protein purification
  • cDNA analyses
  • Expression of recombinant allergens
  • Peptide screening
  • Epitope mapping
  • Structure analyses
  • Novel fish specific diagnostics
  • Oral food challenge
Data collected Not yet available
Primary outcome
Provision of advanced diagnostic capacity leading to greater patient safety

This trial tests whether a treatment plan involving both probiotics and peanut oral immunotherapy (PPOIT) can induce long-term sustained unresponsiveness in children with peanut allergies.

As there is no cure for food allergy, ‘treatment’ usually consists of avoiding foods you are allergic to and knowing how to recognise and manage allergic reactions. A peanut allergy can be especially difficult to manage because it causes more life-threatening reactions (called anaphylaxis) than other food allergies and doesn’t usually resolve like other food allergies commonly do.

PPOIT-3 compares the proportion of children who attain long-term sustained unresponsiveness in PPOIT and placebo treated groups, as well as those in PPOIT and OIT treatment groups.

Contact: [email protected]

Study design This is a phase 3, three-armed, multicentre, randomised (2:2:1), stratified (by study site,
age, skin prick test), blinded, placebo-controlled, parallel-group, superiority trial.

  1. PPOIT = Probiotic and peanut OIT taken daily for 18 months.
  2. OIT =  Probiotic placebo and peanut OIT taken daily for 18 months.
  3. Placebo = Probiotic placebo and OIT placebo taken daily for 18 months.
Investigators Prof Mimi Tang, Prof Susan Prescott, Prof Mike Gold, Prof Katie Allen, Prof Wesley Burks,
Ms Francesca Orsini, Dr Dean Tey, Dr Marnie Robinson, Dr Ee Lyn Su (RCH),
Prof Anne-Louise Ponsonby, Dr Michael O’Sullivan, Dr Patrick Quinn, Dr Kuang Hsiao,
Audrey Dunn-Galvin
Time frame This study is expected to run for 5 years from the start of participant screening to the last participant finishing the study.  The length of the treatment period for each participant is 18 months and the follow up period is 12 months.
2016 – 2021
Funding source National Health and Medical Research Council (1105429)
Location Melbourne, Adelaide & Perth – Australia
Sample 200 peanut-allergic children, aged 1-10 years of age with current peanut allergy confirmed by failed double blind placebo controlled food challenge (DBPCFC) at study screening.
Aims Primary objectives

  • To compare the proportion of children who attain long-term sustained unresponsiveness in PPOIT and placebo treated groups.
  • To compare the proportion of children who attain long-term sustained unresponsiveness in PPOIT and OIT treated groups.

Secondary objectives

  • To compare the proportion of children who attain long-term sustained unresponsiveness in OIT and placebo treated groups.
  • To compare the proportion of children who achieve full desensitisation (pass T1 challenge without reaction) at the end of treatment in (i) PPOIT vs placebo and (ii) PPOIT vs OIT; and (iii) OIT vs placebo.
  • To compare the total cumulative dose of peanut protein tolerated during the end of treatment T1 challenge in (i) PPOIT vs placebo; (ii) PPOIT vs OIT; and (iii) OIT vs placebo.
    This will determine the total dose tolerated in partially desensitized (those who did not achieve full desensitisation) and allergic participants.
  • To compare the proportion of children who can eat peanut in their diet 12 months after end of treatment in (i) PPOIT vs placebo; (ii) PPOIT vs OIT;  and (iii) OIT vs placebo.
  • To compare peanut skin prick test (SPT) wheal size, and peanut and peanut component sIgE and sIgG4 levels at the end of treatment, and 12 weeks and 12 months after treatment in PPOIT, OIT and placebo groups; and to examine their correlation with sustained unresponsiveness.
  • To compare quality of life at the end of treatment and 12 months later in PPOIT, OIT and placebo groups.
Methods A total of 200 children will be randomised to one of three groups (Table 1) at a ratio of
2 PPOIT: 2 OIT: 1 placebo. 80 children allocated to the PPOIT group, 80 to the peanut OIT
group and 40 to the placebo group.Table 1. Treatment groups

GroupGroup NameTreatment
1PPOIT TreatmentProbiotic and Peanut OIT
2OIT TreatmentPlacebo and Peanut OIT
3PlaceboPlacebo and Placebo
Participants will be recruited from Allergy departments at three tertiary paediatric hospitals
in Australia, and from the general community reached by media.

The three sites are: The Royal Children’s Hospital Melbourne / Murdoch Childrens Research
Institute, The Women’s and Children’s Hospital Adelaide, Perth Children’s Hospital

Data collected
  • Parental questionnaire about child’s quality of life
  • Medical review and allergy questionnaires
  • Oral food challenge
  • Study diaries
  • Skin prick testing
  • Blood sample (peanut specific IgE, IgG4, immunological markers)
  • Stool sample (microbiota studies)
Primary outcome

The primary outcome is whether a participant has long-term sustained unresponsiveness  (passed T2 challenge).

This study investigates whether supplementing the mother’s diet during pregnancy and breastfeeding with prebiotic fibre will reduce the development of allergies in her child.

Allergic diseases, including eczema, asthma, hay fever and food allergies, now affect 30-40% of the Australian population. One in every four children will suffer from eczema and asthma, while one in every ten children will have at least one food allergy.
We now know that a baby’s immune system begins to develop even before birth, and that the mother’s diet and her environment in pregnancy can have an important influence. Research now shows that the mother’s gut health may have important effects on the immune development of her baby.
‘Prebiotics’ is a general term for non-digestible dietary fibre that promote health and well-being by inducing the growth and/or activity of beneficial gut bacteria. Prebiotics occur naturally in grains, legumes, vegetables, fruit and breast milk. The supplement and dose to be used in this study has the demonstrated prebiotic properties of a high fibre diet, including favourable effects on gut bacteria and immune health.
This project will recruit pregnant women in Perth to receive either a prebiotic supplement or a placebo supplement. They will be asked to take the supplement from 18-20 weeks gestation until their baby is 6 months of age. The study will then examine whether supplementing the mother’s diet during pregnancy and breastfeeding with the prebiotic fibre will reduce the development of allergies in her child.
Contact emails: [email protected] or [email protected]

Study design Randomised controlled double-blind trial.
Investigators Prof Susan Prescott, Dr Debra Palmer, Prof Desiree Silva, Prof Jeffrey Keelan, Prof Karen Simmer , Prof Charles Mackay, Dr Michael Clarke, A/Prof Richard Allcock, Dr Timo Lassmann
Time frame 2016-2020
Funding source NHMRC project grant
Location Perth, Western Australia
Sample 652 pregnant women and their children
Aims To assess the ability of a maternal dietary intervention of prebiotic supplementation from second trimester of pregnancy to six months post-partum to reduce infant eczema and allergic sensitisation at 12 months of age, relative to the placebo group.
Primary outcome The primary clinical outcome will be medically diagnosed eczema in the infant at 12 months of age

This study is a three arm randomized controlled study designed to assess the effectiveness of short chain fatty acid fiber supplement as an adjuvant in oral peanut immunotherapy for improved sustained unresponsiveness.

Contact: Professor Dianne Campbell.

Study design 58-week, phase 2, 3 arm, single-center interventional randomized controlled trial designed according to CONSORT guidelines.
Investigators CIs- Professor Dianne Campbell University of Sydney, Professor Ralph Nanan University of Sydney, Doctor Trevor Lockett CSIRO (Food and Nutritional Sciences, Doctor Julie Clarke CSIRO Animal, Food and Health Sciences, Doctor Nanju Lee University of New South Wale, Doctor Melanie Wong

AIs-Dr Brigitte Nanan, Professor Charles Mackay, Dr Laurence Macia, Clinical Assoc. Prof Paul Turner, Dr Peter Hsu, Dr Sam Mehr

Time frame 2017 – 2020
Funding source National Health Medical Research Council (APP 1104134)
Location Sydney, Adelaide, Australia.
Sample A total of 167 peanut-allergic subjects will be randomized into 3 arms (67, 67 and 33).
Aims PRIMARY OBJECTIVES

  • Will children with IgE-mediated peanut allergy be safely, effectively and permanently desensitized to peanut using novel dietary adjuvant enhanced Oral Immunotherapy (OIT)?

SECONDARY OBJECTIVES

  • Will this treatment induce regulatory immune responses and modify the gastrointestinal microbiome?
Methods One hundred and sixty seven peanut allergic participants aged 10-16 years who meet inclusion criteria (including DBPCFC) undergo permuted block stratified randomisation (2:2:1 ) into 3 groups for 52 weeks of treatment. Group A (Intervention): Daily peanut OIT and placebo Group B (Intervention): Daily peanut OIT and HAMSB (blinded dietary adjuvant) Group C (Control): Current best practice (strict peanut avoidance, rescue medication, training).
Data collected Primary outcome: The proportion of participants in receiving peanut OIT and dietary fiber supplement (HAMSB) who tolerate 1400mg (or more) roasted peanut at DBPCFC, after cessation of peanut for a 6 week period following 12 months of OIT and HAMSB dietary supplement compared to participants receiving 12 months of peanut OIT and placebo and compared to participants receiving no intervention.
Secondary RCT outcomes: 1-Relative change between groups in the clinical threshold to roasted peanut at study end. 2- Change in quality of life assessments between groups at 0, 6 and 12 months as assessed by validated Food Allergy-Questionnaire (FAQL) in participants and their parents. 3- Safety of OIT using peanut and SCFA adjuvant as defined by frequency and nature of allergic symptoms experienced. 4-Compliance, with study protocol by diary (Groups A and B) and by butyrate faecal analysis (Group B).
Secondary laboratory outcomes: Immunological outcome measures at 0, 6, and 12 months: Laboratory assays will be performed, allowing longitudinal comparisons to be made between participants in Groups A, B and C. Stool microbiota at 0,6,12 months: We aim to determine whether there is a favourable pattern of microbiome composition associated with successful therapy and use of HAMSB.