An observational study in Fecal Microbiota Transplantation, Clostridium Difficile Infection and Gut Microbiome, sponsored by American Gastroenterological Association. Recruiting at 53 sites in 2 countries. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by American Gastroenterological Association · Observational
Among 121 studies in Clostridium Infections with a site in United States — 16 open to participants now, 19 under way, 3 of them phase 3. Clostridium Infections · United States.
Among the 121 studies in Clostridium Infections with a site in United States, this one is the 4th largest by planned enrollment of the 19 observational ones that give a count, is one of 13 that started in 2017, is one of 19 observational ones, reaches primary completion later than 8 of the 18 other live ones, and was the 60th registered.
251 studies on the registry are indexed under Clostridium Infections; 51 are open to participants now.
Browse Clostridium Infections studies →16 of the 121 studies in Clostridium Infections with a site in United States are open now. Recruiting first, the newest first:
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 18–75 · Healthy volunteers
Acurx Pharmaceuticals Inc. · Sites in United States
Ages 18–90
Medical College of Wisconsin · Sites in United States
Ages 18+
University of Michigan · Sites in United States
Ages 18+
AstraZeneca · Sites in United States, Australia, Canada and 11 more countries
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 36 Clostridium Infections studies recruiting now, 22 (61%) set no upper age limit and 8 (22%) stop at 75 or younger; 9 take children under 18; 3 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
121 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 21 · Phase 2 40 · Phase 3 21 · Phase 4 14
First in 1998; this study’s year is marked. 13 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 4,000 is above the median of 226 across 52 observational studies indexed under Clostridium Infections.
Median enrollment 57 across the 102 interventional studies, 132 across the 19 observational. Of the 91 that completed or were terminated, 52 (57%) have results posted.
This tab as a report to print or save as PDF → With an account.
48 of 121 have an industry lead sponsor. The 10 most frequent:
American Gastroenterological Association is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
American Gastroenterological Association has 1 study filed under Clostridium Infections — fewer than ten, so there is no comparison to draw.
7 of the studies in Clostridium Infections with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07221370Phase 3Riverside University Health System Medical CenterEnteral Vancomycin as Primary Prophylaxis Against Clostridioides Difficile Infection in Critically Ill Patients | 2026-12-31 |
| NCT06237452Phase 3Vedanta Biosciences, Inc.VE303 for Prevention of Recurrent Clostridioides Difficile Infection | 2027-06 |
| NCT04305769University of VirginiaAlanyl-glutamine Supplementation for C. Difficile Treatment (ACT) | 2026-12-31 |
| NCT07250724Bactolife A/SC. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI. | 2027-01-15 |
| NCT07285213AstraZenecaPrevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody | 2027-04-20 |
Add all 7 to your calendar (.ics) → With an account.
Among the 121 studies in Clostridium Infections with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Recipient Inclusion Criteria
Donor Inclusion
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
None - Observational
Also known as: Observational
Occurrence of treatment related Adverse Events
Adverse events to be monitored include surgeries, infection, hospitalization, other life-threatening events, death and newly diagnosed diseases.
Time frame: over 10 Years
Disease Re-occurrence Following FMT
Assess effectiveness of FMT by monitoring disease re-occurrence post treatment.
Time frame: over 10 Years
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Started Sep 2017 (actual). Primary completion is estimated for Aug 2027, 119 months after the start.
Of 26 observational studies under Clostridium Infections, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 22. This study's planned 119 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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American Gastroenterological Association