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

NAActive, not recruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

November 11, 2021

Primary Completion Date

September 30, 2024

Study Completion Date

December 31, 2024

Conditions
Peanut AllergyFood Allergy in Children
Interventions
COMBINATION_PRODUCT

PEANUT OIT: Peanut Flour (50% peanut protein) that is prepared under food manufacturing regulations

PROBIOTIC: The probiotic to be used is Lactobacillus rhamnosus GG, supplied as a freeze-dried powder. Probiotic will be prepared under strict Food Manufacturing Regulations. The daily dose of 2x10\^10 cfu will be packed individually in sachets. Participants will be instructed to mix one scoop of the probiotic in water at a temperature NOT exceeding 38 degrees Celsius. The probiotic must be stored at 4 degrees Celsius

COMBINATION_PRODUCT

PEANUT OIT: Peanut Flour (50% peanut protein) that is prepared under food manufacturing regulations

PROBIOTIC PLACEBO: Probiotic Placebo is maltodextrin. The daily dose will be measured using a standardised scoop. Participants will be instructed to mix one scoop of the probiotic in water at a temperature NOT exceeding 38 degrees Celsius. The probiotic should be stored at 2-8 degrees Celsius.

COMBINATION_PRODUCT

PEANUT PLACEBO: Peanut Placebo is maltodextrin powder with food colouring and peanut essence that has similar appearance, taste and smell to the active product.

PROBIOTIC PLACEBO: Probiotic Placebo is maltodextrin. The daily dose will be measured using a standardised scoop. Participants will be instructed to mix one scoop of the probiotic in water at a temperature NOT exceeding 38 degrees Celsius. The probiotic should be stored at 2-8 degrees Celsius.

Trial Locations (4)

Unknown

Department of Paediatrics and Adolescent Medicine, Hong Kong Children's Hospital, Hong Kong

Department of Paediatrics and Adolescent Medicine, Princess Margaret Hospital, Hong Kong

Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong

Department of Paediatrics, Queen Elizabeth Hospital, Hong Kong

All Listed Sponsors
lead

Chinese University of Hong Kong

OTHER