Oral Microbiota Transplantation for Peanut Allergy Treatment

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

This study is testing if a new treatment using gut bacteria can help teenagers with peanut allergies tolerate peanuts better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Ages: 12 Years to 17 Years
• Sex: All
• Sponsor: Boston Children's Hospital (Academic / other)
• Drugs / interventions: Omalizumab, dupilumab, immunotherapy
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT05695261 on ClinicalTrials.gov

What this trial studies

This phase II randomized double-blind placebo-controlled trial evaluates the safety and efficacy of oral encapsulated fecal microbial transplantation therapy in peanut allergic patients aged 12-17. Participants who have shown allergic reactions to peanuts will receive either the microbial transplantation therapy or a placebo after a course of antibiotics. The study aims to determine if this treatment can increase the threshold of peanut reactivity over a period of 28 days and monitor the gut microbiota and immunological responses throughout the process. The trial includes multiple visits for food challenges and assessments of adverse events.

Who should consider this trial

Good fit: Ideal candidates are peanut allergic adolescents aged 12-17 who have experienced dose-limiting symptoms during food challenges.

Not a fit: Patients who do not have a confirmed peanut allergy or those with severe asthma may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for peanut allergic patients by increasing their tolerance to peanuts.

How similar studies have performed: While the approach of microbiota transplantation is novel in the context of peanut allergies, similar studies in other allergic conditions have shown promising results.

Eligibility criteria

The study will enroll 24 peanut allergic patients aged 12-17 who meet the eligibility criteria in Part A and 13 subjects aged 12-17 years who meet eligibility criteria in Part B.

Inclusion Criteria:

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

1. 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).
2. Has a positive SPT to peanut (≥3mm) and/or a positive peanut-specific IgE \>0.35kU/L (Part A only).
3. For asthmatic patients, has a Spirometry or Peak Flow with Measurement of FEV1\>=80% of predicted
4. Has a negative urine hCG test if a female participant.
5. 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.
6. Able to swallow 2 empty capsules size 00.
7. Able to give informed assent and guardian willing to give informed consent.
8. Willing and able to participate in the study requirements, including study visits, food challenges, serial stool collection
9. Willing to undergo telephone or email follow-up to assess for safety and adverse events.
10. Subject has been on maintenance peanut oral immunotherapy for at least a year (part B only).

Exclusion Criteria:

Subjects who fall into any of the following exclusion criteria at the time of screening are not eligible for enrollment into the study.

1. Patients with a history of severe anaphylaxis to any food (hypotension requiring vasopressor support, hypoxia requiring mechanical ventilation, or neurological compromise)
2. 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)
3. 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).
4. 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.
5. Recurrent or chronic infections necessitating frequent systemic (including oral) antibiotic administration.
6. Patients on chronic systemic immunosuppressive therapies.
7. Patients who are diagnosed with active, chronic urticaria.
8. Patients who have received peanut oral immunotherapy within the past 6 months (Part A only).
9. 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.
10. Women who are pregnant or breast feeding or planning to get pregnant during the time of the study.
11. Sexually active female patients who refuse to use contraception from enrollment through the third DBPCFC study visit
12. 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.
13. Patient with current rheumatologic conditions. Exceptions can be made per PI discretion if illness is not expected to affect allergies or treatment.
14. Patients with neutropenia \<1000 cells/uL
15. Patients participating or planning to participate in the next 6 months in interventional research trials. Exceptions can be made per PI discretion.
16. Patients who have received systemic corticosteroids therapy for 1 week or more over the past 60 days.
17. Patient with an allergy to Vancomycin or Neomycin or any component to the capsules.

Where this trial is running

Boston, Massachusetts

• Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Rima Rachid — Boston Children's Hospital
• Study coordinator: Melanie Benitez

Conditions Allergy, Peanut; Peanut Allergy; Peanut Hypersensitivity; Peanut-Induced Anaphylaxis; Food Allergy; Food Allergy Peanut