Open study of Probiotic and Peanut Oral Immunotherapy (PPOIT) for the treatment of peanut allergy in children.

Not Applicable

Completed

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

• Registration Number: ACTRN12615001275550
• Lead Sponsor: Murdoch Childrens Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-23
• Study Completion: 2020-11-12
• Last Update Posted: 14 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Children are eligible for the study if they:
* Are aged between 1 year and 12 years of age,
* If they are >10kg (weight considered safe for the prescription and administration of an Epipen)
* There is a confirmed diagnosis of peanut allergy as defined by a failed DBPCFC to peanut and a positive SPT or sIgE to peanut at screening.

Exclusion Criteria

Children will not be eligible for the study if they have a history of:
* Severe anaphylaxis (as defined by hypotension , collapse, loss of consciousness or hypoxia OR ever needing three (3) or more doses of intramuscular adrenaline or needing intravenous adrenaline infusion for management of anaphylactic reaction)
* FEV1 <85% at rest or FEV1/FVC < 85% at rest or ongoing chronic persistent asthma (as per Australian Asthma Foundation guidelines)
* Underlying medical conditions (eg cardiac disease) that increase the risks associated with anaphylaxis
* Use of beta-blockers
* 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 Probiotics

Study & Design

• Study Type: Interventional
• Study Design: Not specified