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Condition / disease
Location
Status: Recruiting

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

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.

Participants needed: 37
Trial details
Phase: Phase 2Age: 12-17Biological sex: AllType: InterventionalSponsor: Rima RachidUpdated: Aug 24, 2025Locations: 1
Eligibility criteria

Develop dose limiting symptoms to peanut during a DPBCFC conducted in accordance... [+9]

Patients with a history of severe anaphylaxis to any food (hypotension requiring... [+16]