Actively Recruiting
A Phase II Trial to Evaluate the Safety and Efficacy of Oral Encapsulated Microbiota Transplantation Therapy in Peanut Allergic Patients
Led by Rima Rachid · Updated on 2025-08-24
37
Participants Needed
1
Research Sites
7 weeks
Total Duration
On this page
Sponsors
R
Rima Rachid
Lead Sponsor
U
University of Minnesota
Collaborating Sponsor
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
Who Can Participate
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
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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
Trial Site Locations
Total: 1 location
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
M
Melanie Benitez
A
Andrew Xuan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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