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RECRUITING
NCT05695261
PHASE2

Evaluating the Safety and Efficacy of Oral Encapsulated Microbiota Transplantation Therapy in Peanut Allergic Patients

Sponsor: Rima Rachid

View on ClinicalTrials.gov

Summary

This is a phase II trial that aims at evaluating the safety and tolerability of oral encapsulated fecal microbial transplantation therapy (MTT) in peanut allergic patients. In this research the investigators would like to learn more about ways to treat peanut allergies. The primary objective for Part A is to evaluate whether MTT with antibiotic pretreatment can increase the threshold of peanut reactivity during a double-blind placebo-controlled food challenge from \<=100 mg peanut protein to 300 mg after 28 days of MTT /placebo therapy and 4 months post therapy initiation. The primary objective for Part B is to evaluate whether MTT with antibiotic pretreatment can lead to sustained unresponsiveness (SU) defined as tolerating the same dose of peanut protein administered during a food challenge at baseline and 12 weeks after OIT cessation.

Official title: A Phase II Trial to Evaluate the Safety and Efficacy of Oral Encapsulated Microbiota Transplantation Therapy in Peanut Allergic Patients

Key Details

Gender

All

Age Range

12 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

37

Start Date

2023-06-08

Completion Date

2027-03-01

Last Updated

2025-08-24

Healthy Volunteers

No

Interventions

BIOLOGICAL

Microbial Transplantation Therapy

Participants randomized to the MTT/antibiotic arm of PART A will be administered oral MTT capsules over the course of 28 days. Participant enrolled on PART B will be administered oral MTT capsules over the course of 28 days.

DRUG

Antibiotic

Participants randomized to the MTT/antibiotic arm of PART A will receive oral antibiotics for 7 days prior to the MTT administration visit. Participant enrolled on PART B will receive oral antibiotics for 7 days prior to the MTT administration visit.

OTHER

Placebo (in place of MTT)

Participants randomized to the placebo arm of PART A will be administered oral placebo capsules in place of MTT over the course of 28 days.

OTHER

Placebo (in place of antibiotics)

Participants randomized to the placebo arm of PART A will receive oral placebo in place of antibiotics for 7 days prior to the MTT administration visit.

OTHER

Oral Immunotherapy (OIT)

Participant enrolled on PART B will be on maintenance peanut oral immunotherapy (OIT) for their clinical care.

Locations (1)

Boston Children&#39;s Hospital

Boston, Massachusetts, United States