Study of the effectiveness of Probiotics and Peanut Oral Immunotherapy (P-POIT) in inducing desensitisation or tolerance in children with peanut allergy

Phase 2

Completed

• Conditions: Peanut allergy; Inflammatory and Immune System - Allergies

• Registration Number: ACTRN12608000594325
• Lead Sponsor: Royal Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-11-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Children are eligible for the study if they:
1) Are aged between 1 year and 10 years of age
2) Are above 10kg
3) There is a confirmed diagnosis of peanut allergy as defined by:
-a positive food challenge to peanut in the past 2 years AND a positive skin prick test (SPT) or Capsulated Hydrophobic Carrier Polymer- Radioallergosorbent Test (CAP-RAST) to peanut
OR
-a positive food challenge or history of reaction to peanut ever AND a positive SPT greater than or equal to 8mm or a CAP-RAST greater than or equal to 15KU/l to peanut

Exclusion Criteria

Children will not be eligible for the study if they have a history of:
1) severe anaphylaxis (as defined by hypotension , collapse, loss of consciousness or hypoxia)
2) Forced Expiratory Volume in 1 Second (FEV1) of <85% at rest or ongoing chronic persistent asthma (as per Australian Asthma Foundation guidelines)
3) Underlying medical conditions (eg cardiac disease) that increase the risks associated with anaphylaxis
4) Known wheat allergy (the placebo may contain traces of wheat)
5) Use of beta-blockers
6) Inflammatory intestinal conditions, indwelling catheters, gastrostomies or other conditions that may increase the risks of probiotic associated sepsis
7) Cow’s milk allergy, as there may be traces of cow’s milk in the probiotic preparation
8) Already taking probiotics

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To examine whether combined treatment with probiotic and peanut OIT (P-POIT) in children with peanut allergy will induce tolerance to peanut in a greater proportion of children compared with placebo, where tolerance is defined as the ability to tolerate 8g of peanut protein in an oral peanut challenge performed 2 to 12 weeks after discontinuation of P-POIT (in those who pass the first challenge on the last day of P-POIT)[2-12 weeks after discontinuation of P-POIT]