Recruiting

Fecal Microbiota Transplant

Sponsor:

American Gastroenterological Association

Code:

NCT03325855

Conditions

Fecal Microbiota Transplantation

Clostridium Difficile Infection

Gut Microbiome

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

None - Observational

Study Details

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

Conditions

Fecal Microbiota Transplantation

Clostridium Difficile Infection

Gut Microbiome

Study ID

NCT03325855

Start date

Sep 20, 2017

Status verified date

Jan, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

4000 participants

Anticipated

Interventions and Outcome Measures

Interventions

None - Observational

None - Observational

Primary outcome measure

  • Occurrence of treatment related Adverse Events [ Time Frame: over 10 Years ]
  • Disease Re-occurrence Following FMT [ Time Frame: over 10 Years ]

Central Contacts and Locations

Central contacts

Sonya Serra, MSc

3019412616sserra@gastro.org

Lydia Fredell, MA

3019419797lfredell@gastro.org

Locations

Stanford University

Recruiting

Redwood City, California, United States, 94063

Principal Investigator:

Irene Sonu, MD

Sutter Roseville Medical Center

Recruiting

Roseville, California, United States, 95661

Principal Investigator:

Ronald Hsu, M.D.

University of California San Francisco

Recruiting

San Francisco, California, United States, 94115

Principal Investigator:

Max Brondfield, MD

Yale New Haven Hospital

Recruiting

Hamden, Connecticut, United States, 06518

Principal Investigator:

Paul Feuerstadt, MD

University of Miami, Miller School of Medicine

Recruiting

Miami, Florida, United States, 33136

Principal Investigator:

David Kerman, MD

Emory University School of Medicine

Recruiting

Atlanta, Georgia, United States, 30307

Principal Investigator:

Nirja Mehta, MD

The University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Principal Investigator:

Tiffany Patton, M.D.

Loyola University of Chicago/ Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

Principal Investigator:

Ayokunle Abegunde, M.D.

Indiana University School of Medicine

Recruiting

Indianapolis, Indiana, United States, 46202

Principal Investigator:

Monika Fischer, M.D., MSc.

University of Kansas Medical Center Research Institute

Recruiting

Kansas City, Kansas, United States, 66160

Principal Investigator:

Mollie Jackson, M.D.

Ochsner

Recruiting

New Orleans, Louisiana, United States, 70121

Principal Investigator:

Arnab Ray, MD

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Principal Investigator:

Stacy Kahn, M.D.

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Principal Investigator:

Jessica Allegretti, MD

UMass Memorial Health

Recruiting

Worcester, Massachusetts, United States, 01604

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Principal Investigator:

Patricia Bloom, M.D.

Henry Ford Health Hospital

Recruiting

Detroit, Michigan, United States, 48202

Mayo Clinic - Division of Pediatric Gastroenterology

Recruiting

Rochester, Minnesota, United States, 55905

Principal Investigator:

Imad Absah, MD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Principal Investigator:

Sahil Khanna, MD

Rutgers

Recruiting

New Brunswick, New Jersey, United States, 08901

Principal Investigator:

Lea Ann Chen, MD

New York University School of Medicine

Recruiting

New York, New York, United States, 10016

Principal Investigator:

Jordan Axelrad, MD

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10021

Principal Investigator:

Carl Crawford, MD

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Principal Investigator:

Ari Grinspan, MD

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Principal Investigator:

Ajay Gulati, M.D.

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Principal Investigator:

Melissa Hershman, M.D.

University of Wisconsin - Madison

Recruiting

Madison, Wisconsin, United States, 53705

Principal Investigator:

Nasia Safdar, MD

The Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Principal Investigator:

Daniel Stein, M.D.

More Information

Sponsor

American Gastroenterological Association

Last update posted

Jan 21, 2026

Last verified

Jan, 2026

Keywords

  • FMT
  • CDI
  • Fecal Matter Transplant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by American Gastroenterological Association on 2026-01-21.