Fecal Microbiota Transplant National Registry

This is an observational study, meaning no new treatments are being tested. Instead, researchers are creating a national registry of 4,000 patients who receive Fecal Microbiota Transplantation (FMT) or other gut-related microbiota products. The goal is to understand the short-term and long-term safety and effectiveness of these treatments over 10 years. You can join if you are receiving FMT or a similar product within 90 days of consenting, have internet or phone access, and can provide informed consent. Donors can also join if they provide a stool sample and can give informed consent. The study is looking to see how often side effects happen and if the disease comes back after FMT.

Study design
This is an observational study enrolling 4,000 participants across 75 sites in North America. It is not testing a specific treatment but rather collecting information on existing practices.
What's involved
If you are a recipient, you will provide information at regular intervals up to 10 years after FMT, including through your healthcare provider and direct communication with researchers. If you are a donor, you will provide a stool sample.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 10 years after Fecal Microbiota Transplantation (FMT).

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NCT03325855

Fecal Microbiota Transplant National Registry

Recruiting
Not specifiedAll AgesObservational
American Gastroenterological Association
~4,000 participants
Updated 2026-01-21 on ClinicalTrials.gov
What's tested:None - Observational

At a glance

Recruiting sites
26 of 53 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of treatment related Adverse Events
Measured over over 10 Years
+1 more outcome measured
Fecal Microbiota Transplantation
Clostridium Difficile Infection
Gut Microbiome
53 sites across 26 states
California6
Illinois6
New York6
Florida3
Massachusetts3
Michigan3
New Jersey3
Maryland2
  • Gary D Wu, MD · PRINCIPAL_INVESTIGATOR · Co-Director, PennCHOP Microbiome Program
  • Colleen Kelly, MD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital
  • Loren Laine, MD · PRINCIPAL_INVESTIGATOR · Yale University

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Incarceration
  • Occurrence of treatment related Adverse Eventsover 10 Years

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

  • Disease Re-occurrence Following FMTover 10 Years

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