Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03325855

Fecal Microbiota Transplant National Registry

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

Recruiting

Interested in participating?

Request Info

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alberta, Edmonton, Alberta, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

None - Observational

Other

None - Observational

Other names: Observational

Primary outcomes

  1. Occurrence of treatment related Adverse Events

    Time frame: over 10 Years

    Adverse events to be monitored include surgeries, infection, hospitalization, other life-threatening events, death and newly diagnosed diseases.

  2. Disease Re-occurrence Following FMT

    Time frame: over 10 Years

    Assess effectiveness of FMT by monitoring disease re-occurrence post treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Lydia Fredell, MA

CONTACT

[email protected]

3019419797

Sonya Serra, MSc

CONTACT

[email protected]

3019412616

Sponsors and collaborators

Lead sponsor

American Gastroenterological Association

Other

Collaborators

  • Commure, Inc
  • Loyola University Chicago
  • OpenBiome
  • University of California, San Diego
  • University of Minnesota
  • University of Pennsylvania

Registry information

Acronym: FMT

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Oct 30, 2017
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.