Fecal Microbiota Transplant National Registry

Recruiting

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

• Registration Number: NCT03325855
• Lead Sponsor: American Gastroenterological Association

Brief 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.

Study Timeline

• Study Start: 2017-09-20
• Study First Submitted: 2017-10-17
• Study First Submitted QC: 2017-10-27
• Study First Posted: 2017-10-30
• Status Verified: 2024-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Primary Completion: 2027-08
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of treatment related Adverse Events	over 10 Years	Adverse events to be monitored include surgeries, infection, hospitalization, other life-threatening events, death and newly diagnosed diseases.
Disease Re-occurrence Following FMT	over 10 Years	Assess effectiveness of FMT by monitoring disease re-occurrence post treatment.

Trial Locations

Locations (50)

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States

Phoenix Children's Hospital; 🇺🇸 Phoenix, Arizona, United States

Children's Hospital of Los Angeles; 🇺🇸 Los Angeles, California, United States

University of California; 🇺🇸 Los Angeles, California, United States

Stanford University; 🇺🇸 Redwood City, California, United States

Sutter Roseville Medical Center; 🇺🇸 Roseville, California, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

Ventura Clinical Trials; 🇺🇸 Ventura, California, United States

Yale New Haven Hospital; 🇺🇸 Hamden, Connecticut, United States

MedStar Georgetown University Hospital; 🇺🇸 Georgetown, District of Columbia, United States

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