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.