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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Rima Rachid
Study ID
NCT05695261
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Microbial Transplantation Therapy — BIOLOGICAL
    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.
  • Antibiotic — DRUG
    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.
  • Placebo (in place of MTT) — OTHER
    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.
  • Placebo (in place of antibiotics) — OTHER
    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.
  • Oral Immunotherapy (OIT) — OTHER
    Participant enrolled on PART B will be on maintenance peanut oral immunotherapy (OIT) for their clinical care.

Study Details

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.

Key Dates

Start date
Jun 8, 2023
Status verified
Feb 2025
Primary completion
Jan 11, 2027
Completion
Mar 1, 2027

Study Design

Enrollment
37 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PART A: antibiotic / MTT
    Study subjects randomized to the experimental arm will receive oral antibiotics for 7 days as a way to modulate the composition of the gastrointestinal microbiota. Upon completion of oral antibiotics, subjects randomized to the experimental arm will be administeredf MTT under medical supervision. Subjects will be monitored and then discharged. Subjects will be instructed to take MTT capsules daily for 27 days.
  • Active Comparator: PART A: placebo / placebo
    Study subjects randomized to the placebo arm will receive oral placebo capsules instead of oral antibiotics, for 7 days, at the same frequency and capsule amount per dose. Upon completion of 7 days of placebo (matching the antibiotics given in the experimental arm), subjects randomized to the placebo arm will be administered capsules of placebo (matching the MTT capsules given in the experimental arm) under medical supervision. Subjects will be monitored and then discharged. Subjects will be instructed to take placebo capsules daily for 27 days.
  • Other: PART B: open label antibiotic / MTT
    In Part B will enroll 13 participants who are peanut allergic and are on maintenance peanut oral immunotherapy (OIT). Participants will undergo an open label food challenge (OFC) up to 2,000 mg peanut protein. These participants will be pre-treated with open label oral Vancomycin and Neomycin over 7 days prior to receiving open label MTT. This part of the study is not randomized or double blind.

Primary Outcome Measure

PART A: Changes in threshold of peanut reactivity during DBPCFC (<=100 mg to 300 mg peanut protein) [ Time Frame: 4 months post MTT ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children&#39;s HospitalBostonMassachusetts02115
Melanie Benitez
[email protected]
617-355-6117
Andrew Xuan
[email protected]
Rima Rachid, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Boston Children&#39;s Hospital· Boston, MA

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