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

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.

Conditions

• Allergy, Peanut
• Peanut Allergy
• Peanut Hypersensitivity
• Peanut-Induced Anaphylaxis
• Food Allergy
• Food Allergy Peanut

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.

Sponsors & Collaborators

• University of Minnesota

  collaborator OTHER

• Rima Rachid

  lead OTHER

Principal Investigators

• Rima Rachid · Boston Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-08

Primary Completion

2027-01-11

Completion

2027-03-01

FDA Drug

Yes

Countries

• United States

Study Locations