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

PHASE2RecruitingINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

June 8, 2023

Primary Completion Date

January 11, 2027

Study Completion Date

March 1, 2027

Conditions
Allergy, PeanutPeanut AllergyPeanut HypersensitivityPeanut-Induced AnaphylaxisFood AllergyFood Allergy Peanut
Interventions
BIOLOGICAL

Microbial 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."

DRUG

Antibiotic

"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."

OTHER

Placebo (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.

OTHER

Placebo (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.

OTHER

Oral Immunotherapy (OIT)

Participant enrolled on PART B will be on maintenance peanut oral immunotherapy (OIT) for their clinical care.

Trial Locations (1)

02115

RECRUITING

Boston Children's Hospital, Boston

All Listed Sponsors
collaborator

University of Minnesota

OTHER

lead

Rima Rachid

OTHER