Actively Recruiting
Evaluating 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
194 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
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
Official 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 patients aged 12 to 17 years
- Dose limiting symptoms to peanut during a double-blind placebo-controlled food challenge at 1 mg, 3 mg, 10 mg, 30 mg, or 100 mg peanut protein (Part A only)
- Positive peanut skin prick test (>=3 mm) and/or peanut-specific IgE >0.35 kU/L (Part A only)
- For asthmatic patients, spirometry or peak flow showing FEV1 >=80% of predicted
- Negative urine hCG test if female participant
- Agree to use an acceptable single-barrier form of birth control if female of childbearing potential and sexually active
- 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 study visits, food challenges, and stool collections
- Willing to undergo telephone or email follow-up to assess safety and adverse events
- 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 vasopressor support, mechanical ventilation, or neurological compromise
- Current diagnosis of IgE mediated reactions to foods other than peanut, tree nuts, egg, and milk with exceptions based on MTT contents (Part A and B specific)
- Chronic illness other than controlled asthma (mild intermittent, mild-persistent or moderate persistent), mild eczema, or allergic rhinitis unless approved by investigator
- Recurrent or chronic infections requiring frequent systemic antibiotics
- Use of chronic systemic immunosuppressive therapies
- Diagnosis of active, chronic urticaria
- Receipt of peanut oral immunotherapy within the 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 from enrollment through study
- Gastrointestinal conditions including inflammatory bowel disease, eosinophilic esophagitis, food protein induced enterocolitis, uncontrolled reflux or constipation, esophageal dysmotility, swallowing dysfunction, delayed gastric emptying, pill esophagitis, or recent aspiration pneumonia
- Current rheumatologic conditions unless approved by investigator
- Neutropenia with neutrophil count <1000 cells/uL
- Participation or planned participation in other interventional trials within 6 months unless approved by investigator
- Use of systemic corticosteroids for 1 week or more in past 60 days
- Allergy to Vancomycin, Neomycin, or any capsule components
AI-Screening
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Trial Site Locations
Total: 1 location
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
M
Melanie Benitez
CONTACT
A
Andrew Xuan
CONTACT
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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