A multicentre, randomized, controlled trial of Probiotic and Peanut Oral Immunotherapy (PPOIT) in inducing desensitisation or tolerance in children with peanut allergy compared with Oral Immunotherapy (OIT) alone and with placebo.

Not Applicable

Completed

• Conditions: Food Allergy; Peanut Allergy; Inflammatory and Immune System - Allergies

• Registration Number: ACTRN12616000322437
• Lead Sponsor: Murdoch Childrens Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-11
• Study Completion: 2020-12-22
• Last Update Posted: 29 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

Children are eligible for the study if they meet all of these criteria:
- Children aged between 1 year and 10 years of age
- greater than 7kg (the weight considered safe for the administration of an Epipen/EpiPen Jr)
- Confirmed diagnosis of peanut allergy as defined by a failed Double-Blind, Placebo-Controlled Food Challenge (CBPCFC) with peanut and a positive SPT or SIgE to peanut at screening.

Exclusion Criteria

Children are not eligible for the study if they meet any of these criteria:
- History of severe anaphylaxis (as defined by persistent hypotension, collapse, loss of consciousness, persistent hypoxia or ever needing more than three doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction)
- Severe anaphylaxis during the study entry DBPCFC (defined as persistent hypotension, collapse, loss of consciousness, persistent hypoxia, or requiring three or more doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction)
- FEV1 less than 85% at rest and FEV1/FVC is less than or equal to 85% at rest or ongoing chronic persistent asthma (as per Australian Asthma Foundation guidelines)
- Underlying medical conditions (e.g. cardiac disease) that increase the risks associated with anaphylaxis
- Use of beta-blockers, and ACE inhibitors
- Inflammatory intestinal conditions, indwelling catheters, gastrostomies, immune-compromised states, post-cardiac and/or gastrointestinal tract surgery, critically-ill and those requiring prolonged hospitalisation or other conditions that may increase the risks of probiotic associated sepsis
- Already taking probiotic supplements within the past 6 months (does not include formula)
- Reacting to the placebo component during the study entry DBPCFC
- Have received other food immunotherapy treatment in the preceding 12 months
- Currently taking immunomodulatory therapy (including allergen immunotherapy)
- Past or current major illness that in the opinion of the Site Investigator may affect the subject’s ability to participate in the study e.g. increased risk to the participant
- Subjects who in the opinion of the Site Investigator are unable to follow the protocol
- Another family member already enrolled in the trial (to maintain safety and blinding)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of participants with 8-week sustained unresponsiveness (passed T1 and T2 challenges - determined by performing a DBPCFC) in PPOIT vs OIT. [T2 - 8 weeks after final day of maintenance treatment.];Proportion of participants with 8-week sustained unresponsiveness (passed T1 and T2 challenges - determined by performing a double blind placebo controlled food challenge (DBPCFC)) in PPOIT vs placebo. [T2 - 8 weeks after final day of maintenance treatment.]