NCT03325855

Fecal Microbiota Transplant National Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 4,000 (estimated)
• Sponsor: American Gastroenterological Association · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

A national data registry of patients receiving fecal microbiota transplantation (FMT) or other gut-related-microbiota products designed to prospectively assess short and long-term safety and effectiveness

Detailed description

This registry will prospectively enroll 4,000 patients who undergo FMT at 75 sites throughout North America. Information on FMT methodology employed (e.g., screening of donor and recipient, preparation, FMT delivery) will be collected from each site. The indication for FMT as well as baseline information on recipient will also be collected. Following FMT, patients will be followed at regular intervals up to 10 years post FMT. This will include follow-up information from the patient's healthcare provider at 1 month, 6 months, 1 year, and 2 years after FMT as well as direct communication with patients at least annually up to 10 years after FMT. Follow-up information collected will be designed to assess potential short-term and long-term safety and effectiveness.

Conditions

• Fecal Microbiota Transplantation
• Clostridium Difficile Infection
• Gut Microbiome

Interventions

Type	Name	Description
OTHER	None - Observational	None - Observational

Timeline

• Start date: 2017-09-20
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2017-10-30
• Last updated: 2026-01-21

Locations

53 sites across 2 countries: United States, Canada