Actively Recruiting

All Genders
ID03325855

Fecal Microbiota Transplant National Registry

Led by American Gastroenterological Association · Updated on 2026-01-21

4000

Participants Needed

53

Research Sites

N/A

Total Duration

On this page

Sponsors

A

American Gastroenterological Association

Lead Sponsor

O

OpenBiome

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying patients who receive fecal microbiota transplantation (FMT) or other gut-related microbiota products to understand the short-term and long-term safety and effectiveness of these treatments. This national data registry aims to collect detailed information on how FMT is performed, why it is done, and the baseline health of patients receiving it. The study is observational and will enroll around 4,000 patients at 75 sites across North America. Participants will undergo FMT or receive related microbiota products, and information about the donor and recipient screening, preparation, and delivery methods will be collected from each site. The registry will track patients for up to 10 years after their treatment, with follow-up data gathered from healthcare providers at 1 month, 6 months, 1 year, and 2 years post-FMT, as well as annual communication with patients for the full duration. During the study, researchers will collect data on any treatment-related side effects and whether the original disease returns after FMT. Follow-up will include regular assessments to monitor safety and effectiveness over time. Participants will be asked to provide information through healthcare provider reports and direct contact, with the total participation lasting up to 10 years to ensure long-term monitoring.

CONDITIONS

Brief Title

Fecal Microbiota Transplant National Registry

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to give informed consent
  • Receiving fecal microbiota transplantation or other gut-related microbiota product within 90 days after giving consent
  • Access to internet and/or telephone
  • Providing stool sample for fecal microbiota transplantation (donor)
Not Eligible

You will not qualify if you...

  • Incarceration

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - Up to 90 days

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Monitoring

Duration - Up to 10 years

Participants who undergo fecal microbiota transplantation are observed for safety and effectiveness.

Visits at 1 month, 6 months, 1 year, 2 years, and at least annually up to 10 years

Trial Site Locations

Total: 53 locations

1

Phoenix Children's Hospital

Phoenix, Arizona, United States, 85016

Withdrawn

2

Children's Hospital of Los Angeles

Los Angeles, California, United States, 90027

Active, Not Recruiting

3

University of California

Los Angeles, California, United States, 90095

Withdrawn

4

Stanford University

Redwood City, California, United States, 94063

Actively Recruiting

5

Sutter Roseville Medical Center

Roseville, California, United States, 95661

Actively Recruiting

6

University of California San Francisco

San Francisco, California, United States, 94115

Actively Recruiting

7

Ventura Clinical Trials

Ventura, California, United States, 93003

Withdrawn

8

Yale New Haven Hospital

Hamden, Connecticut, United States, 06518

Actively Recruiting

9

MedStar Georgetown University Hospital

Georgetown, District of Columbia, United States, 20007

Active, Not Recruiting

10

Best Quality Research, Inc.

Hialeah, Florida, United States, 33016

Withdrawn

11

University of Miami, Miller School of Medicine

Miami, Florida, United States, 33136

Actively Recruiting

12

GI Pros

Naples, Florida, United States, 34102

Withdrawn

13

Emory University School of Medicine

Atlanta, Georgia, United States, 30307

Actively Recruiting

14

The University of Chicago

Chicago, Illinois, United States, 60637

Actively Recruiting

15

University of Chicago School of Medicine

Chicago, Illinois, United States, 60637

Active, Not Recruiting

16

NorthShore University Health System

Evanston, Illinois, United States, 60201

Terminated

17

Loyola University Medical Center

Maywood, Illinois, United States, 60153

Active, Not Recruiting

18

Loyola University of Chicago/ Loyola University Medical Center

Maywood, Illinois, United States, 60153

Actively Recruiting

19

Carle Foundation Hospital

Urbana, Illinois, United States, 61801

Completed

20

Indiana University School of Medicine

Indianapolis, Indiana, United States, 46202

Actively Recruiting

21

University of Kansas Medical Center Research Institute

Kansas City, Kansas, United States, 66160

Actively Recruiting

22

Ochsner

New Orleans, Louisiana, United States, 70121

Actively Recruiting

23

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States, 21287

Completed

24

American Gastroenterological Association

Bethesda, Maryland, United States, 20814

Active, Not Recruiting

25

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

26

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

27

UMass Memorial Health

Worcester, Massachusetts, United States, 01604

Actively Recruiting

28

St. Joseph Mercy Hospital

Ann Arbor, Michigan, United States, 48105

Completed

29

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

30

Henry Ford Health Hospital

Detroit, Michigan, United States, 48202

Actively Recruiting

31

Mayo Clinic - Division of Pediatric Gastroenterology

Rochester, Minnesota, United States, 55905

Actively Recruiting

32

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

33

Valley Hospital and Medical Center

Las Vegas, Nevada, United States, 89146

Active, Not Recruiting

34

Atlantic Health System

Morristown, New Jersey, United States, 07960

Completed

35

Rutgers

New Brunswick, New Jersey, United States, 08901

Actively Recruiting

36

Penn Medicine Princeton Health

Plainsboro, New Jersey, United States, 08536

Not Yet Recruiting

37

Concorde Medical Group

New York, New York, United States, 10016

Withdrawn

38

New York University School of Medicine

New York, New York, United States, 10016

Actively Recruiting

39

Weill Cornell Medicine - Pediatric

New York, New York, United States, 10021

Withdrawn

40

Weill Cornell Medicine

New York, New York, United States, 10021

Actively Recruiting

41

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Actively Recruiting

42

Gastroenterology Group of Rochester, LLP

Rochester, New York, United States, 14618

Completed

43

University of North Carolina

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

44

Oregon Health & Science University

Portland, Oregon, United States, 97239

Actively Recruiting

45

Temple University

Philadelphia, Pennsylvania, United States, 19140

Active, Not Recruiting

46

Brown University Women's Medicine and Collaborative

Providence, Rhode Island, United States, 02904

Active, Not Recruiting

47

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Active, Not Recruiting

48

Texas Children's Hospital / Baylor College of Medicine

Houston, Texas, United States, 77030

Withdrawn

49

Baylor Research Institute - Scott & White Medical Center

Temple, Texas, United States, 76508

Completed

50

West Virginia University

Morgantown, West Virginia, United States, 26506

Not Yet Recruiting

51

University of Wisconsin - Madison

Madison, Wisconsin, United States, 53705

Actively Recruiting

52

The Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

53

University of Alberta

Edmonton, Alberta, Canada, T6G2X8

Withdrawn

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Research Team

S

Sonya Serra, MSc

L

Lydia Fredell, MA

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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