Fecal Microbiota TransplantationFMTNCT03325855
Fecal Microbiota Transplant National Registry
An observational study of Fecal Microbiota Transplantation and Clostridium Difficile Infection, run by American Gastroenterological Association at 53 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fecal Microbiota Transplantation, Clostridium Difficile Infection, Gut Microbiome
- What is being tested?
- None - Observational
- How many people
- 4,000 participants
- Where
- 53 sitesin 2 countries
- Study dates
- 20 Sep 2017to Aug 2027
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Incarceration
Trial locations and contacts
53 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
53 sites in 2 countries
United States52 sites, 28 recruiting
- Completed
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48105
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Max Macgregor
Patricia Bloom, M.D.
- Recruiting
Emory University School of Medicine
Atlanta, Georgia, 30307
Drew Siskin
Nirja Mehta, MD
- Completed
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
- Active, not recruiting
American Gastroenterological Association
Bethesda, Maryland, 20814
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Jenna Simes
Stacy Kahn, M.D.
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Grace Hardwick
Jessica Allegretti, MD
- Recruiting
University of North Carolina
Chapel Hill, North Carolina, 27599
Rachel Cooke
Ajay Gulati, M.D.
- Recruiting
The University of Chicago
Chicago, Illinois, 60637
Derrick Judkins
Tiffany Patton, M.D.
- Active, not recruiting
University of Chicago School of Medicine
Chicago, Illinois, 60637
- Recruiting
Henry Ford Health Hospital
Detroit, Michigan, 48202
El-Nachef, MD
- Terminated
NorthShore University Health System
Evanston, Illinois, 60201
- Active, not recruiting
MedStar Georgetown University Hospital
Georgetown, District of Columbia, 20007
- Recruiting
Yale New Haven Hospital
Hamden, Connecticut, 06518
Candace Cotto, RN
Paul Feuerstadt, MD
- Withdrawn
Best Quality Research, Inc.
Hialeah, Florida, 33016
- Withdrawn
Texas Children's Hospital / Baylor College of Medicine
Houston, Texas, 77030
- Recruiting
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Sarah Pardue Brennan, RN CCRP
Monika Fischer, M.D., MSc.
- Recruiting
University of Kansas Medical Center Research Institute
Kansas City, Kansas, 66160
Mollie Jackson, M.D.
Mollie Jackson, M.D.
- Active, not recruiting
Valley Hospital and Medical Center
Las Vegas, Nevada, 89146
- Active, not recruiting
Children's Hospital of Los Angeles
Los Angeles, California, 90027
- Withdrawn
University of California
Los Angeles, California, 90095
- Recruiting
University of Wisconsin - Madison
Madison, Wisconsin, 53705
Shelly Zimbric
Nasia Safdar, MD
- Active, not recruiting
Loyola University Medical Center
Maywood, Illinois, 60153
- Recruiting
Loyola University of Chicago/ Loyola University Medical Center
Maywood, Illinois, 60153
Dejan Micic, M.D.
Ayokunle Abegunde, M.D.
- Recruiting
University of Miami, Miller School of Medicine
Miami, Florida, 33136
Priscilla De Fatima Madero
David Kerman, MD
- Recruiting
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Anita Ward
Daniel Stein, M.D.
- Not yet recruiting
West Virginia University
Morgantown, West Virginia, 26506
Asad Pervez, M.D.
Asad Pervez, M.D.
- Completed
Atlantic Health System
Morristown, New Jersey, 07960
- Withdrawn
GI Pros
Naples, Florida, 34102
- Active, not recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
- Recruiting
Rutgers
New Brunswick, New Jersey, 08901
Susan Cataldo
Lea Ann Chen, MD
- Recruiting
Ochsner
New Orleans, Louisiana, 70121
James Gore, M.D.
Arnab Ray, MD
- Withdrawn
Concorde Medical Group
New York, New York, 10016
- Recruiting
New York University School of Medicine
New York, New York, 10016
Philip Dulock
Jordan Axelrad, MD
- Withdrawn
Weill Cornell Medicine - Pediatric
New York, New York, 10021
- Recruiting
Weill Cornell Medicine
New York, New York, 10021
Dominique Gay
Carl Crawford, MD
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Josephine Mitcham
Ari Grinspan, MD
- Active, not recruiting
Temple University
Philadelphia, Pennsylvania, 19140
- Withdrawn
Phoenix Children's Hospital
Phoenix, Arizona, 85016
- Not yet recruiting
Penn Medicine Princeton Health
Plainsboro, New Jersey, 08536
Sheryl Smolensky
Kevin Skole, MD
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Melissa Hershman, M.D.
Melissa Hershman, M.D.
- Active, not recruiting
Brown University Women's Medicine and Collaborative
Providence, Rhode Island, 02904
- Recruiting
Stanford University
Redwood City, California, 94063
Irene Sonu, MD
- Recruiting
Mayo Clinic - Division of Pediatric Gastroenterology
Rochester, Minnesota, 55905
Mary Manyara
Imad Absah, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Becky Hofschulte
Sahil Khanna, MD
- Completed
Gastroenterology Group of Rochester, LLP
Rochester, New York, 14618
- Recruiting
Sutter Roseville Medical Center
Roseville, California, 95661
Tatiana Vidal
Ronald Hsu, M.D.
- Recruiting
University of California San Francisco
San Francisco, California, 94115
Rachael Delacruz
Max Brondfield, MD
- Completed
Baylor Research Institute - Scott & White Medical Center
Temple, Texas, 76508
- Completed
Carle Foundation Hospital
Urbana, Illinois, 61801
- Withdrawn
Ventura Clinical Trials
Ventura, California, 93003
- Recruiting
UMass Memorial Health
Worcester, Massachusetts, 01604
Anne Foley
About this study
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
Read the 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.
- Being tested
- None - Observational
- Keywords
- FMT, CDI, Fecal Matter Transplant
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None - ObservationalOther
Also called Observational
None - Observational
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of treatment related Adverse Events
Adverse events to be monitored include surgeries, infection, hospitalization, other life-threatening events, death and newly diagnosed diseases.
Measured: over 10 Years
Disease Re-occurrence Following FMT
Assess effectiveness of FMT by monitoring disease re-occurrence post treatment.
Measured: over 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start20 Sep 2017
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal Microbiota TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- American Gastroenterological Association
- Sponsor type
- University, hospital or other
- Collaborators
- OpenBiome, University of California, San Diego, University of Pennsylvania, University of Minnesota, Loyola University Chicago, Commure, Inc
- Responsible party
- Sponsor
- Investigators
- Gary D Wu, MD, Principal investigator, Co-Director, PennCHOP Microbiome ProgramColleen Kelly, MD, Principal investigator, Brigham and Women's HospitalLoren Laine, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325855
- Sponsor's protocol ID
- AmericanGA
- Acronym
- FMT
- Status last verified
- Jan 2026
- First submitted
- 17 Oct 2017
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplant National Registry
- ClinicalTrials.gov ID
- NCT03325855
- Acronym / sponsor ID
- FMT / AmericanGA
- Keywords
- FMT, CDI, Fecal Matter Transplant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- American Gastroenterological AssociationUniversity, hospital or other
- Collaborators
- OpenBiome, University of California, San Diego, University of Pennsylvania, University of Minnesota, Loyola University Chicago, Commure, Inc
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 30 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Recipient Inclusion Criteria
- Donor Inclusion
Key exclusion criteria (1 listed)
- Incarceration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None - ObservationalAlso: ObservationalNone - Observational | Other | – |
Primary outcome
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.
Disease Re-occurrence Following FMT
Time frame: over 10 Years
Assess effectiveness of FMT by monitoring disease re-occurrence post treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
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Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical Study
Necrotizing Enterocolitis (NEC), Necrotizing Enterocolitis of Newborn
Active, not recruitingPhase 2
Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
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Tributyrin for Progressive Supranuclear Palsy (PSP): Virtual Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
53 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fecal Microbiota Transplantation and Clostridium Difficile Infection, run by American Gastroenterological Association at 53 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sonya Serra, MSc (3019412616, sserra@gastro.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of treatment related Adverse Events (time frame: over 10 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.