Randomised, controlled trial evaluating the effectiveness of probiotic and egg oral immunotherapy at inducing desensitisation or tolerance in participants with egg allergy compared with placebo (Probiotic Egg Allergen Oral Immunotherapy for Treatment of Egg Allergy: PEAT study).

Phase 2

Active, not recruiting

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

• Registration Number: ACTRN12619000480189
• Lead Sponsor: Murdoch Children's Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-22
• Last Update Posted: 14 November 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Subjects are eligible for the study if they meet all of the following criteria:
- Aged between 5 and 30 years of age
- Confirmed diagnosis of egg allergy as defined by a failed DBPCFC and a positive SPT or sIgE to egg at screening

Exclusion Criteria

Subjects are not eligible for the study if they meet any of the following criteria:
•Subjects who are on an egg ladder diet (except baked egg)
•History of severe anaphylaxis (as defined by persistent hypotension, collapse, loss of consciousness, persistent hypoxia or ever needing more than three (3) doses of intramuscular adrenaline (epinephrine) or an intravenous adrenaline (epinephrine) 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 more than 3 doses of intramuscular adrenaline (epinephrine) or an intravenous adrenaline (epinephrine) infusion for management of an allergic reaction)
•FEV1 less than 85% predicted at rest and FEV1/FVC is less than or equal to 85% predicted at rest (for those participants able to perform spirometry testing) 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 or food containing probiotics in the last month.
•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
•History of suspected or biopsy-confirmed eosinophilic oesophagitis (EoE)
•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)
•Non-English speaking participants and families
•Participants 18 years or over (RCH site only)

NOTE: participants with other food allergies are NOT excluded from participating in this trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of participants who attain sustained unresponsiveness in active and placebo groups, <br>Sustained unresponsiveness will be defined as passing the Double Blind Placebo Controlled Food Challenge (DBPCFC) at T2, 8 weeks after end-of-treatment. [T2 - 8 weeks after final day of maintenance treatment.]