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

NCT05695261 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: P00043954
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• PART A: Changes in threshold of peanut reactivity during DBPCFC (<=100 mg to 300 mg peanut protein)

  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.

  4 months post MTT

• PART B: Achievement of sustained unresponsiveness after 12 weeks of MTT

  PART B: Achievement of sustained unresponsiveness after 12 weeks of MTT therapy combined with peanut OIT followed by 12 weeks therapy cessation

  12 weeks

Secondary Outcomes (6)

• PART A: Changes in threshold of peanut reactivity during DBPCFC (<=100 mg to 600 mg peanut protein)

  4 months post MTT

• PART A & B: Adverse Events

  8 months

• PART A & B: Changes in Skin Test Wheal Size and IgE level

  8 months

• PART A & B: Changes in Gut Microbial Composition

  8 months

• PART A & B: Changes in Biomarkers

  8 months

Study Arms (3)

PART A: antibiotic / MTT

EXPERIMENTAL

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.

Biological: Microbial Transplantation Therapy; Drug: Antibiotic

PART A: placebo / placebo

ACTIVE COMPARATOR

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: Placebo (in place of MTT); Other: Placebo (in place of antibiotics)

PART B: open label antibiotic / MTT

OTHER

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.

Biological: Microbial Transplantation Therapy; Drug: Antibiotic; Other: Oral Immunotherapy (OIT)

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.

PART A: antibiotic / MTT; PART B: open label antibiotic / MTT

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.

PART A: antibiotic / MTT; PART B: open label antibiotic / MTT

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.

PART A: placebo / placebo

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.

PART A: placebo / placebo

Oral Immunotherapy (OIT) OTHER

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

PART B: open label antibiotic / MTT

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Develop dose limiting symptoms to peanut during a DPBCFC conducted in accordance with PRACTALL (Practical Issues in Allergology, Joint United States/European Union Initiative) guidelines at 1 mg, 3 mg, 10 mg, 30 mg, or 100 mg peanut protein (Part A only).
• Has a positive SPT to peanut (≥3mm) and/or a positive peanut-specific IgE \>0.35kU/L (Part A only).
• For asthmatic patients, has a Spirometry or Peak Flow with Measurement of FEV1\>=80% of predicted
• Has a negative urine hCG test if a female participant.
• Agrees to use an acceptable single-barrier form of birth control from enrollment through the exit DBPCFC study visit if female of childbearing potential and sexually active. An example of a single-barrier method of contraception includes condoms or oral contraceptives. Acceptable methods of birth control include implants, injectables, combined oral contraceptives, some intrauterine contraceptive devises (IUDs), sexual abstinence, a vasectomized partner, the contraceptive patch, the contraceptive ring, and condoms.
• Able to swallow 2 empty capsules size 00.
• Able to give informed assent and guardian willing to give informed consent.
• Willing and able to participate in the study requirements, including study visits, food challenges, serial stool collection
• Willing to undergo telephone or email follow-up to assess for safety and adverse events.
• Subject has been on maintenance peanut oral immunotherapy for at least a year (part B only).

You may not qualify if:

• Patients with a history of severe anaphylaxis to any food (hypotension requiring vasopressor support, hypoxia requiring mechanical ventilation, or neurological compromise)
• For Part A, patients with current diagnosis of an IgE mediated reactions to food (excluding allergic reactions to peanut, tree nuts, egg and milk, provided that MTT does not contain traces of these food estimated to be above the LOAEL in 5 capsules combined, and excluding oral allergy syndrome, and excluding other foods that the MTT donor avoided)
• For Part B, patients with current diagnosis of an IgE mediated reactions to food (excluding allergic reactions to peanut, tree nuts, egg and milk, provided that MTT does not contain traces of tree nuts, egg and milk estimated to be above the LOAEL in 4 capsules, and excluding oral allergy syndrome, excluding the food that the patient is undergoing immunotherapy to, and excluding other foods that the MTT donor avoided).
• Patients with chronic illness other than controlled asthma that is mild intermittent, mild- persistent or moderate persistent, mild eczema and allergic rhinitis. Exceptions can be made per PI discretion if illness is not expected to affect allergies or treatment.
• Recurrent or chronic infections necessitating frequent systemic (including oral) antibiotic administration.
• Patients on chronic systemic immunosuppressive therapies.
• Patients who are diagnosed with active, chronic urticaria.
• Patients who have received peanut oral immunotherapy within the past 6 months (Part A only).
• Patients who are on the up-dosing phase of aeroallergen immunotherapy or patients who have received Omalizumab or dupilumab therapy within the past 6 months.
• Women who are pregnant or breast feeding or planning to get pregnant during the time of the study.
• Sexually active female patients who refuse to use contraception from enrollment through the third DBPCFC study visit
• Patient with GI conditions including inflammatory bowel disease, eosinophilic esophagitis, food protein induced enterocolitis, uncontrolled reflux despite medication, uncontrolled chronic constipation despite medication, esophageal dysmotility, swallowing dysfunction, delayed gastric emptying syndromes, pill esophagitis or history of aspiration pneumonia within 3 months prior to screening.
• Patient with current rheumatologic conditions. Exceptions can be made per PI discretion if illness is not expected to affect allergies or treatment.
• Patients with neutropenia \<1000 cells/uL
• Patients participating or planning to participate in the next 6 months in interventional research trials. Exceptions can be made per PI discretion.

Sponsors & Collaborators

• Rima Rachid: lead
• University of Minnesota: collaborator

Study Sites (1)

Boston Children&#39;s Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Peanut Hypersensitivity; Food Hypersensitivity

Interventions

Anti-Bacterial Agents; Immunotherapy

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Immunomodulation; Biological Therapy; Therapeutics

Study Officials

• Rima Rachid

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melanie Benitez

CONTACT

617-355-6117; Melanie.Benitez@childrens.harvard.edu

Andrew Xuan

CONTACT

Andrew.Xuan@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician, Division of Immunology

Model Details: All individuals enrolled in Part A of the study patients will be randomized on a 1:1 ratio to receive either MTT with antibiotics (arm 1) or placebo/placebo (arm 2). The unblinding will occur at the end of the study. All individuals enrolled to Part B of the study (arm 3) will receive open label MTT and antibiotics.

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 23, 2023
• Study Start: June 8, 2023
• Primary Completion (Estimated): January 11, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)