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Fecal Microbiota Transplant National Registry (FMT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03325855
Recruitment Status : Recruiting
First Posted : October 30, 2017
Last Update Posted : February 17, 2023
University of California, San Diego
RX.Health Inc.
University of Pennsylvania
University of Minnesota
Loyola University Chicago
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Fecal Microbiota Transplantation Clostridium Difficile Infection Gut Microbiome Other: None - Observational

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 4000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Fecal Microbiota Transplant National Registry
Actual Study Start Date : September 20, 2017
Estimated Primary Completion Date : August 2027
Estimated Study Completion Date : August 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Intervention Details:
  • Other: None - Observational
    None - Observational
    Other Name: Observational

Primary Outcome Measures :
  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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients receiving FMT or other gut-related-microbiota products and the donors providing specimens for the enrolled patients' FMT. Patients will be enrolled regardless of race, gender, ethnicity, or age.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03325855

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Contact: Sonya Serra, MSc 3019412616 sserra@gastro.org
Contact: Yanina Nersesova, MA 3019412600 ynersesova@gastro.org

Show Show 49 study locations
Sponsors and Collaborators
American Gastroenterological Association
University of California, San Diego
RX.Health Inc.
University of Pennsylvania
University of Minnesota
Loyola University Chicago
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Principal Investigator: Gary D Wu, MD Co-Director, PennCHOP Microbiome Program
Principal Investigator: Colleen Kelly, MD Brown University
Principal Investigator: Loren Laine, MD Yale School of Medicine
  Study Documents (Full-Text)

Documents provided by American Gastroenterological Association:
Study Protocol  [PDF] June 20, 2017

Additional Information:

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Responsible Party: American Gastroenterological Association
ClinicalTrials.gov Identifier: NCT03325855    
Other Study ID Numbers: AmericanGA
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: February 17, 2023
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by American Gastroenterological Association:
Fecal Matter Transplant
Additional relevant MeSH terms:
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Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses