What is microbial transplantation therapy studying for peanut allergy?

Microbial transplantation therapy is being studied to see if it can increase peanut tolerance and sustain this tolerance in young people with peanut allergies. Researchers want to understand if combining this therapy with antibiotics can safely change the immune response to peanuts. The study is led by Rima Rachid and aims to improve treatment options for peanut allergy.

Who may be eligible for this peanut allergy clinical trial?

Young people aged 12 to 17 with confirmed peanut allergy may be eligible. Participants must have a positive skin or blood test for peanut allergy and meet health criteria such as controlled asthma and no severe reactions requiring emergency care. Both males and females can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this peanut allergy clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. Personal expenses like travel may vary and are not guaranteed to be covered. Participants can expect to receive all necessary treatments and assessments as part of the study without charge.

Actively Recruiting

Phase 2

Age: 12Years - 17Years

All Genders

ID05695261

Phase II Study of Oral Encapsulated Microbiota Transplantation Therapy with Antibiotic Pretreatment for Treating Peanut Allergy in Adolescents Aged 12 to 17

Led by Rima Rachid · Updated on 2025-08-24

Participants Needed

Research Sites

7 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating oral encapsulated fecal microbial transplantation therapy MTT for safety and tolerability in young people aged 12 to 17 with peanut allergies. This phase II trial aims to see if MTT combined with antibiotic pretreatment can increase the amount of peanut protein a patient can tolerate during a food challenge and whether it can help sustain this tolerance after stopping oral immunotherapy. The study involves two parts a randomized, placebo-controlled phase Part A and an open-label phase Part B for those already on maintenance peanut oral immunotherapy OIT.

CONDITIONS

Brief Title

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

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	MTT + Antibiotic	Placebo + Placebo	Peanut OIT (standard care)
What it is	Oral microbiota transplantation therapy with a 7‑day antibiotic course followed by 28 days of MTT capsules	Matching placebo capsules for both antibiotic and MTT over the same durations	Oral peanut immunotherapy typically involves gradually increasing oral doses of peanut protein under clinical supervision
Role in trial	Investigational active treatment tested for safety and efficacy	Control arm receiving placebo under the same regimen	Current non‑trial approach used in clinical practice for desensitization
Primary use	Attempt to increase peanut tolerance threshold via microbiota modulation	Serve as control to assess MTT effect on tolerance	Increase threshold of allergic reaction to peanut through controlled exposure
How it is given or performed	Seven days of oral antibiotic followed by daily MTT capsules for 28 days	Matching placebo antibiotic for seven days and placebo capsules for 28 days	Supervised escalation of oral peanut protein doses over time, usually starting with low dose and increasing to maintenance
Evidence status	Efficacy not yet established; primary outcomes pending	No effect expected beyond placebo mechanism	Clinical trials show OIT desensitizes 60‑80% of patients and some achieve sustained unresponsiveness
Important risks	Unknown safety profile; requires monitoring for adverse events	Expected minimal risk beyond placebo and procedure-related assessments	OIT carries increased risk of allergic reactions including anaphylaxis; epinephrine required in ~25% of cases
Important limitations	Single small pediatric age cohort aged 12‑17, sequential parts with limited sample sizes	Placebo arm lacks real‑world comparator and may limit generalizability	OIT is investigational in many settings, not curative, requires long‑term dosing and carries risk of serious reactions

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 12Years - 17Years

All Genders

Eligibility Criteria

You may qualify if you...

Male and female participants aged 12 to 17 years
Develop dose limiting symptoms to peanut during a double-blind placebo-controlled food challenge with up to 100 mg peanut protein (Part A only)
Positive skin prick test to peanut (≥3mm) and/or positive peanut-specific IgE >0.35 kU/L (Part A only)
For asthmatic patients, lung function with FEV1 ≥80% predicted
Negative urine hCG test if female
Agree to use acceptable single-barrier contraception if female of childbearing potential and sexually active
Able to swallow two empty size 00 capsules
Able to give informed assent with guardian consent
Willing and able to participate in study visits, food challenges, and stool collections
Willing to complete telephone or email follow-up for safety
On maintenance peanut oral immunotherapy for at least one year (Part B only)

You will not qualify if you...

History of severe anaphylaxis to any food requiring emergency treatment
Current IgE mediated reactions to certain foods beyond peanut, tree nuts, egg, and milk with some exceptions (different for Parts A and B)
Chronic illnesses other than controlled asthma, mild eczema, or allergic rhinitis (exceptions possible)
Frequent or chronic infections requiring systemic antibiotics
Use of chronic systemic immunosuppressive therapy
Active chronic urticaria
Received peanut oral immunotherapy within past 6 months (Part A only)
On up-dosing phase of aeroallergen immunotherapy or received Omalizumab or dupilumab within past 6 months
Pregnant, breastfeeding, or planning pregnancy during study
Sexually active females refusing contraception
Gastrointestinal conditions like inflammatory bowel disease or severe reflux
Current rheumatologic conditions (exceptions possible)
Neutropenia with counts less than 1000 cells/uL
Participation in other interventional research trials within 6 months
Systemic corticosteroid use for 1 week or more in past 60 days
Allergy to Vancomycin, Neomycin, or capsule components

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Run-in Period

Duration - 7 days

Participants randomized to the experimental arms will receive oral antibiotics or placebo for 7 days to modulate gastrointestinal microbiota before transplantation therapy.

1 visit to start antibiotics or placebo

Treatment

Duration - Approximately 28 days

Participants will receive oral Microbial Transplantation Therapy (MTT) or placebo capsules under medical supervision and continue taking capsules daily for 26 to 28 days.

1 supervised administration visit plus daily capsule intake at home

Post-treatment Assessment

Duration - Up to 6 months after treatment

Participants return to the clinic for food challenges and biomarker assessments to evaluate changes in peanut reactivity and immune response.

Multiple visits including a second food challenge within 2 weeks post-treatment, a follow-up challenge at 4 months, and an exit visit at 6 months

Research Team

Melanie Benitez

Andrew Xuan

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

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Frequently Asked Questions

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Phase II Study of Oral Encapsulated Microbiota Transplantation Therapy with Antibiotic Pretreatment for Treating Peanut Allergy in Adolescents Aged 12 to 17

On this page

Sponsors

AI-Summary

What this Trial Is About

Brief Title

How This Trial Compares With Other Options

Who Can Participate

Eligibility Criteria

Your Study Journey

Research Team

How is the study designed?

Similar Trials

Study of Sensitization to Peach and Five Other Plant Allerge...

Study of Boiled Cashew Oral Immunotherapy to Treat Cashew Nu...

Comparing Clinical and Home Introduction of Cows Milk in Inf...

Frequently Asked Questions

What is microbial transplantation therapy studying for peanut allergy?

Who may be eligible for this peanut allergy clinical trial?

Is there any cost to participate in this peanut allergy clinical trial?

Will I receive microbial transplantation therapy or a placebo?

How will peanut tolerance be measured during this study?

What happens after this peanut allergy clinical trial ends?

Can I leave this peanut allergy clinical trial if I change my mind?

Not the Right Trial for You?

On this page

Sponsors

Sponsors

How This Trial Compares With Other Options

Who Can Participate

Eligibility Criteria

Your Study Journey

How is the study designed?

Similar Trials

Study of Sensitization to Peach and Five Other Plant Allerge...

Study of Boiled Cashew Oral Immunotherapy to Treat Cashew Nu...

Comparing Clinical and Home Introduction of Cows Milk in Inf...

Frequently Asked Questions

What is microbial transplantation therapy studying for peanut allergy?

Who may be eligible for this peanut allergy clinical trial?

Is there any cost to participate in this peanut allergy clinical trial?

Will I receive microbial transplantation therapy or a placebo?

How will peanut tolerance be measured during this study?

What happens after this peanut allergy clinical trial ends?

Can I leave this peanut allergy clinical trial if I change my mind?

Sponsors