drugset / Trial / NCT05165329

A Randomized, Controlled Trial of Probiotic and Peanut Oral Immunotherapy (PPOIT) in Inducing Tolerance in Hong Kong Children With Peanut Allergy Compared With Oral Immunotherapy (OIT) Alone and With Placebo

NCT05165329

Unknown 90 enrolled Chinese University of Hong Kong
RandomizedParallel-groupQuadruple-blindTreatment

Summary

At present there is no cure for food allergy. People with a food allergy need to avoid the food they are allergic to in order to stay safe. However we know that accidental exposure is common. Researchers have begun to look at the effectiveness of 'oral immunotherapy' as a treatment for food allergy but results have been mixed. This study is a randomized controlled trial to evaluate the effectiveness of Probiotic and Peanut Oral Immunotherapy (PPOIT) in inducing tolerance in children with peanut allergy compared with Oral Immunotherapy (OIT) alone and with Placebo. Children will take increasing doses of peanut protein and a set amount of probiotic until a total of 18 months treatment is completed. Children will be tested for peanut allergy at the start of the study, at the end of PPOIT treatment T1 (18 months) and T2 (8 weeks) and T3 (1year) after treatment.

Timeline

Start
2021-11-11
Primary completion
2024-09-30
Completion
2024-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Lactobacillus rhamnosus GG Other / unclassified 2e+10 unknown Oral
Subject Peanut Flour Protein / enzyme biologic 2 g Oral

Indications