Fecal Microbiota Transplant National Registry (FMT)

American Gastroenterological Association

Status: Enrolling

Conditions: Gut Microbiome; Clostridium Difficile Infection; Fecal Microbiota Transplantation

Treatments: Other: None - Observational

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03325855

AmericanGA

Details and patient eligibility

About

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

Full 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.

Enrollment: 4,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Recipient Inclusion Criteria

  • Ability to give informed consent
  • Receiving FMT or other gut-related microbiota product within 90 days after providing consent
  • Access to internet and/or telephone

• Donor Inclusion

  • Ability to give informed consent
  • Providing stool sample for FMT

Exclusion criteria

• Incarceration

Trial design