OIT (Peanut) Study at Children's Hospital at Westmead

An invitation from the Children's Hospital at Westmead:

The Allergy department at Children’s Hospital at Westmead are currently recruiting for an oral peanut immunotherapy (OIT) trial for children aged 10-16 years with a diagnosed peanut allergy who are able to travel to The Children’s Hospital at Westmead every 2-3 weeks.

We are trying to see if a modified dietary fibre can help establish sustained unresponsiveness to peanut after one year of peanut OIT. The CSIRO have added a short chain fatty acid called butyrate onto a dietary fibre (butyrylated high amylose maize starch, HAMSB). This fibre passes through to the large intestine where gut bacteria release the butyrate. Butyrate acts on regulatory T cells, which are thought to promote tolerance. Blood, stool and questionnaires will be collected.  

To be eligible, we need to confirm a current peanut allergy using a double blind placebo control food challenge (DBPCFC). Eligible children are randomised into one of three arms: a control arm (current standard treatment) with continued peanut avoidance, rescue medications and action plans; a peanut OIT arm with adjuvant “active” fibre HAMSB; and a peanut OIT arm with a placebo fibre (LAMS, a low amylose starch). Each child has an 80% chance of receiving peanut OIT, 50% of those allocated to HAMSB. The control group will be contacted regularly to monitor their progress. Peanut OIT arms will come to hospital every 2-3 weeks for dose increases.   After 12 months, children receiving peanut OIT will stop OIT and fibre supplementation for 6 weeks. All children will undergo a final DBPCFC to determine tolerance. Children in the control arm will be offered 12 months of peanut OIT and HAMSB supplementation after the final DBPCFC.

Exclusion criteria includes: previous admission to intensive care for peanut anaphylaxis; clinically significant chronic illness (except asthma, rhinitis or eczema); first 12 months of immunotherapy (SCIT/SLIT) for aeroallergen(s); anti-IgE therapy, immunosupressants, beta-blocker or ACE inhibitor therapy; subjects reacting to <10mg or to >1440mg peanut protein cumulative dose at initial DBPCFC, poorly controlled asthma; pregnancy; or participants unwilling or unable to fulfill study requirements.

Please visit our webpage at www.schn.health.nsw.gov.au/research/clinical-trials/peanut-allergy-trial for information packs for parents and children. If you have anyone that may be eligible for study enrolment, or if you are after further information, please contact the OPIA research team via email (This email address is being protected from spambots. You need JavaScript enabled to view it.)

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