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Australian Clinical Trials

Clinical Trial Details

Oral peanut immunotherapy with a modified dietary starch adjuvant for treatment of peanut allergy in children aged 10-16 years.

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Trial Information

Broad Health Condition Inflammatory and Immune System

Specific Health ConditionAllergies

Trial FocusTreatment

Recruitment Details

Recruitment status
Active, not recruiting

Recruitment State

The Children's Hospital at Westmead - Westmead

2145 - Westmead

Anticipated date of first participant enrolment31/07/2017

Anticipated date of last participant enrolment16/08/2019

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Trial summary

Childhood peanut allergy is increasing, affecting 3% of Australian children. It is the food allergy that persists into adult life, and the most likely to be associated with death due to accidental exposure.  It involves the allergy antibody, IgE, which stimulates allergy cells to release chemicals that cause allergic symptoms. There is no current cure. Management is by avoidance with emergency plans and medication in case of accidental exposure. 
Immunotherapy (IT) is thought to be the most likely strategy to offer a “cure” for food allergy. Immunotherapy has been shown to be effective in the management of aeroallergen and venom allergy. This technique involves regular and prolonged exposure to the allergen in question, initially starting with very small doses and then increasing the dose over a period of time to a level where the person does not respond with an allergic reaction when re-exposed to it. Food immunotherapy trials have so far only had a few participants and  often achieved only temporary desensitization which is lost rapidly when treatment is stopped, and also have a high rate of side effects. 
Gut microbes are implicated in food allergy. They can increase the levels of small chain fatty acids (SCFA), namely acetate, butyrate and propionate, in the gut  by fermenting fibre- leading to significant changes to bacteria present in the gut (i.e. the gut microbiome), with  increased beneficial bacteria promoting a non-allergic environment.  
Experiments in mice fed a high-fiber diet or SCFAs found they were protected from food allergy. In particular, they had increased oral tolerance to peanuts with an increase in the number and function of  immune cells important in controlling allergic reactions .
This study aims to examine whether using a dietary fibre supplement which is high in a key short chain fatty acid- butyrate -whilst using small and increasing daily doses of peanut in peanut allergic children and teenagers will provide them with sustained unresponsiveness to peanut and render them non allergic (or tolerant ) to peanut.


Key inclusion criteria

Children aged 10-16 years with a diagnosis of peanut allergy with a positive skin prick test to a commercially available peanut extract (wheal at least 3mm larger than the negative control) and confirmation of clinical reactivity to roasted peanut in a double blind, placebo-controlled food challenge (DBPCFC) with a cumulative threshold of >9mg but <3000mg of peanut protein; tolerant of soy (DBPCFC is given in a soy-based matrix) at a food challenge; parents, or  legal guardians, must give informed consent and the child must also agree to partake in the study.

Minimum age10 Years

Maximum age16 Years

GenderBoth males and females

Can Healthy volunteers participate? No

Key exclusion criteria

Previous admission to intensive care unit for the management of a peanut allergic reaction; clinically significant chronic disease other than eczema, rhinitis or asthma; poorly controlled asthma in the last 3 months (as defined by clinican judgement with reference to the ICON consensus) or asthma requiring oral corticosteroids in the previous 3 months; those in the first year of  immunotherapy (subcutaneous or sublingual) for respiratory allergens; those receiving anti-IgE therapy, oral immunosuppressants, beta-blockers or ACE inhibitor therapy; a clinical allergy to soya or sunflower seed; tolerance to roasted peanut in a double blind, placebo-controlled food challenge with thresholds <10mg or 3000mg or more peanut protein; pregnancy; or unwilling or being unable to fulfil study requirements.
Contact details and further information

Sponsor Primary Sponsor Type: Government body
Primary Sponsor Name: Sydney Children's Hospital Network
Primary Sponsor Address: Sydney Children's Hospital Network Locked Bag 4001 WESTMEAD NSW 2145
Primary Sponsor Country: Australia

Trial IDACTRN12617000914369


Contact person for information and recruitmentDr
Peter Hsu
Department of Allergy and Immunology The Children's Hospital at Westmead Cnr Hawkesbury Rd and Hainsworth St WESTMEAD NSW 2145

Email contact Further information