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Evaluating the Safety and Efficacy of Oral Encapsulated Fecal Microbiota Transplant in Peanut Allergic Patients

Peanut Allergy Clinical Trial

Official title:
A Phase I Open Label Trial to Evaluate the Safety and Efficacy of Oral Encapsulated Fecal Microbiota Transplantation in Peanut Allergic Patients

Clinical Trial Summary

This is a Phase I trial to evaluate the safety and efficacy of oral encapsulated fecal microbiota transplantation (FMT) in the treatment of peanut allergy. In this research the investigators would like to learn more about ways to treat peanut allergies. There is currently no known cure for peanut allergy. The primary aim is to assess safety and tolerability of oral FMT in patients with peanut allergy aged 18-40 years.

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02960074
Study type Interventional
Source Boston Children's Hospital
Contact
Status Completed
Phase Phase 1
Start date March 3, 2017
Completion date July 28, 2021
View Details
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