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. Identifier: NCT03325855
Recruitment Status : Recruiting
First Posted : October 30, 2017
Last Update Posted : April 11, 2018
University of California, San Diego
Icahn School of Medicine at Mount Sinai
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.

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 2021
Estimated Study Completion Date : August 2026

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

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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 identifier (NCT number): NCT03325855

Contact: Sonya Serra, MSc 3019412616
Contact: Yanina Nersesova, MA 3019412600

United States, California
Children's Hospital of Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Roy Leong, CCRP         
Principal Investigator: Sonia Michail, MD         
Sutter Roseville Medical Center Recruiting
Roseville, California, United States, 95661
Contact: Ronald Hsu, M.D.         
Principal Investigator: Ronald Hsu, M.D.         
United States, Connecticut
Yale New Haven Hospital Recruiting
Hamden, Connecticut, United States, 06518
Contact: Candace Cotto, RN         
Principal Investigator: Paul Feuerstadt, MD         
United States, Illinois
NorthShore University Health System Recruiting
Evanston, Illinois, United States, 60201
Contact: Edessa David         
Principal Investigator: Eugene Yen, MD         
Carle Foundation Hospital Recruiting
Urbana, Illinois, United States, 61801
Contact: Christine Canfield, BS, CCRP         
Principal Investigator: Lyn Tangen, MD         
United States, Indiana
Indiana University School of Medicine Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Emmalee Phelps         
Principal Investigator: Monika Fischer, M.D., MSc.         
United States, Maryland
American Gastroenterological Association Active, not recruiting
Bethesda, Maryland, United States, 20814
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: McKenzie Leier         
Principal Investigator: Stacy Kahn, M.D.         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Edina Shu         
Principal Investigator: Jessica Allegretti, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Patricia Kammer         
Principal Investigator: Sahil Khanna, MD         
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Josephine Mitcham         
Principal Investigator: Ari Grinspan, MD         
Gastroenterology Group of Rochester, LLP Recruiting
Rochester, New York, United States, 14618
Contact: Julie Lawatsch         
Principal Investigator: Jonathan Goldstein, MD         
United States, Rhode Island
Brown University Women's Medicine and Collaborative Recruiting
Providence, Rhode Island, United States, 02904
Contact: Patrizia Curran         
Principal Investigator: Colleen Kelly, MD         
Sponsors and Collaborators
American Gastroenterological Association
University of California, San Diego
Icahn School of Medicine at Mount Sinai
  Study Documents (Full-Text)

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

Responsible Party: American Gastroenterological Association Identifier: NCT03325855     History of Changes
Other Study ID Numbers: AmericanGA
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: January 2018

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