Evaluating Oral Encapsulated Microbiota Transplantation Therapy for Peanut Allergy
This study is testing an oral encapsulated microbiota transplantation therapy (MTT) to see if it's safe and effective for people with peanut allergy. Researchers want to learn if this therapy, sometimes given after a short course of antibiotics, can help reduce allergic reactions to peanuts. The study is looking for 37 participants, aged 12 to 17, who have a peanut allergy. For some participants (Part A), success means being able to tolerate more peanut protein (from 100 mg to 300 mg) after treatment. For others (Part B), success means achieving sustained unresponsiveness to peanuts after 12 weeks of MTT. The current recruitment status is unclear.
- Study design
- This is a Phase 2 interventional study with two parts. Part A is a randomized, double-blind, placebo-controlled trial, while Part B is an open-label study. It plans to enroll 37 participants.
- What's involved
- Participants in Part A will receive antibiotics or placebo for 7 days, then oral MTT capsules or placebo for 28 days. They will have food challenges and blood draws, with visits up to 6 months after treatment. Part B participants will also receive antibiotics and MTT capsules for 28 days, and will be on maintenance peanut oral immunotherapy.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants in Part A will be followed for 6 months after the end of treatment. Participants in Part B will be assessed for sustained unresponsiveness after 12 weeks of MTT.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Evaluating the Safety and Efficacy of Oral Encapsulated Microbiota Transplantation Therapy in Peanut Allergic Patients
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Rima Rachid · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital
Who to contact
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What this trial measures
- PART A: Changes in threshold of peanut reactivity during DBPCFC (<=100 mg to 300 mg peanut protein)4 months post MTT
PART A: Changes in threshold of peanut reactivity during DBPCFC after 28 days of MTT from \<=100 mg to 300 mg peanut protein and 4 months post therapy initiation.
- PART B: Achievement of sustained unresponsiveness after 12 weeks of MTT12 weeks
PART B: Achievement of sustained unresponsiveness after 12 weeks of MTT therapy combined with peanut OIT followed by 12 weeks therapy cessation