Evaluating the Safety and Efficacy of Oral Encapsulated Fecal Microbiota Transplant in Peanut Allergic Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 10
Summary
- Conditions
- Peanut Allergy
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 40 years
- Gender
- Both males and females
Description
This is a study of fecal microbiota transplantation (FMT) in the treatment of peanut allergy. The primary aim is to assess safety and tolerability of oral encapsulated FMT in patients with peanut allergy aged 18-40 years. A total of 15 patients with peanut allergy will be enrolled after they fail a ...
This is a study of fecal microbiota transplantation (FMT) in the treatment of peanut allergy. The primary aim is to assess safety and tolerability of oral encapsulated FMT in patients with peanut allergy aged 18-40 years. A total of 15 patients with peanut allergy will be enrolled after they fail a screening food challenge to peanut. 10 patients will be given oral encapsulated frozen FMT over 1-2 days. 5 additional patients will receive antibiotics prior to being given oral encapsulated frozen FMT over 1-2 days. Patients will undergo a second and third food challenge after receiving FMT. The expected duration of the study for each subject will be one year. Stool collection, skin testing and blood samples will be done serially.
Tracking Information
- NCT #
- NCT02960074
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Rima Rachid, MD Boston Children's Hospital
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