A Phase II Trial to Evaluate the Safety and Efficacy of Oral Encapsulated Microbiota Transplantation Therapy in Peanut Allergic Patients
Rima Rachid
Summary
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.
Description
Part A is a This is a phase II randomized double-blind placebo-controlled arm trial that aims at evaluating the efficacy and safety and tolerability of microbial transplantation therapy (MTT) in peanut allergic patients. After reacting to \<=100 mg peanut protein during initial DBPCFC, patients will be randomized to receive either oral Vancomycin and Neomycin or placebo/placebo for 7 days. Patients will then come to the Experimental and Therapeutic Unit (ETU) to receive orally 5 capsules of MTT or placebo under medical supervision. Patients will then take 5 capsules of MTT or placebo the next…
Eligibility
- Age range
- 12–17 years
- Sex
- All
- Healthy volunteers
- No
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 posit…
Interventions
- BiologicalMicrobial Transplantation Therapy
Participants randomized to the MTT/antibiotic arm of PART A will be administered oral MTT capsules over the course of 28 days. Participant enrolled on PART B will be administered oral MTT capsules over the course of 28 days.
- DrugAntibiotic
Participants randomized to the MTT/antibiotic arm of PART A will receive oral antibiotics for 7 days prior to the MTT administration visit. Participant enrolled on PART B will receive oral antibiotics for 7 days prior to the MTT administration visit.
- OtherPlacebo (in place of MTT)
Participants randomized to the placebo arm of PART A will be administered oral placebo capsules in place of MTT over the course of 28 days.
- OtherPlacebo (in place of antibiotics)
Participants randomized to the placebo arm of PART A will receive oral placebo in place of antibiotics for 7 days prior to the MTT administration visit.
- OtherOral Immunotherapy (OIT)
Participant enrolled on PART B will be on maintenance peanut oral immunotherapy (OIT) for their clinical care.
Location
- Boston Children's HospitalBoston, Massachusetts