Standardized Microbiota Transplant Therapy in Crohn's Disease

PHASE2RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

January 15, 2025

Primary Completion Date

June 15, 2029

Study Completion Date

June 15, 2029

Conditions
Crohn Disease
Interventions
BIOLOGICAL

MTP-101C

MTP-101C composed of double-encapsulated freeze-dried healthy donor microbiota. The fecal microbiota is frozen in the presence of a lyoprotectant (trehalose), freeze-dried, and double encapsulated into hypromellose capsules (Lonza, Morristown, NJ). Each capsule contains ≥ 1 x 10 11 and ≤ 2.0 x 10 11 bacterial cells.

BIOLOGICAL

MTP-101S

MTP-101S contains identical healthy donor microbiota double encapsulated in VCaps Plus (Lonza). These capsules are also composed of hypromellose but disintegrate in the proximal small bowel. Each capsule contains ≥ 1 x 10 11 and ≤ 2.0 x 10 11 bacterial cells.

Trial Locations (1)

55414

RECRUITING

University of Minnesota, Minneapolis

All Listed Sponsors
lead

University of Minnesota

OTHER