Standardized Microbiota Transplant Therapy in Crohn's Disease

Crohn's disease (CD) develops because of a disruption of homeostasis between the gut microbiota and the host immune system resulting in excessive inflammation in the intestinal tract. Current drug therapies for CD are directed at the immune system. The emergence of fecal microbiota transplantation (FMT) for the treatment of recurrent C. difficile infections (rCDI) has opened a frontier of restorative therapies targeting the gut microbiome. This study aims to assess if two forms of encapsulated FMT material (MTP101C and MTP101S) can effectively engraft in the ileum and colon of individuals with CD. This study will also assess how the impact of CD phenotype impacts engraftment. Finally this study will explore symptom and endoscopic changes before and after these two therapies.

NCT Number	NCT06631586
Lead Sponsor	University of Minnesota
Conditions	Crohn Disease
Enrollment	120 participants
Start Date	2025-01-15
Primary Completion	2029-06-15 (estimated)
Study Completion	2029-06-15 (estimated)
Updated on ClinicalTrials.gov	2026-06-22