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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Allergy, Peanut, Peanut Allergy, Peanut Hypersensitivity, Peanut-Induced Anaphylaxis, Food Allergy, Food Allergy Peanut

In brief

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 facts

Study ID

NCT05695261

Run by

Rima Rachid

People needed

37

Starts

2023-06-08

Expected to finish

2027-03-01

Last updated by the study team

2025-08-24

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female young adults aged 12-17 years, who meet all the following inclusion criteria, will be enrolled in the study.
• 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…

• Subjects who fall into any of the following exclusion criteria at the time of screening are not eligible for enrollment into the study.
• 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.
• Patients who have received systemic corticosteroids therapy for 1 week or more over the past 60 days.
• Patient with an allergy to Vancomycin or Neomycin or any component to the capsules.

Where it is running

• Boston Children&#39;s Hospital — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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