Trial record 1 of 2 for:
FMT National registry
Fecal Microbiota Transplant National Registry (FMT)
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| ClinicalTrials.gov Identifier: NCT03325855 |
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Recruitment Status :
Recruiting
First Posted : October 30, 2017
Last Update Posted : February 17, 2023
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Sponsor:
American Gastroenterological Association
Collaborators:
OpenBiome
University of California, San Diego
RX.Health Inc.
University of Pennsylvania
University of Minnesota
Loyola University Chicago
Information provided by (Responsible Party):
American Gastroenterological Association
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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 |
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 2027 |
| Estimated Study Completion Date : | August 2027 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Bowel Movement
Intervention Details:
- Other: None - Observational
None - ObservationalOther Name: Observational
Primary Outcome Measures :
- 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.
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.
Criteria
Inclusion Criteria:
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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
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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 ClinicalTrials.gov identifier (NCT number): NCT03325855
Contacts
| Contact: Sonya Serra, MSc | 3019412616 | sserra@gastro.org | |
| Contact: Yanina Nersesova, MA | 3019412600 | ynersesova@gastro.org |
Locations
Show 49 study locations
Sponsors and Collaborators
American Gastroenterological Association
OpenBiome
University of California, San Diego
RX.Health Inc.
University of Pennsylvania
University of Minnesota
Loyola University Chicago
Investigators
| Principal Investigator: | Gary D Wu, MD | Co-Director, PennCHOP Microbiome Program | |
| Principal Investigator: | Colleen Kelly, MD | Brown University | |
| Principal Investigator: | Loren Laine, MD | Yale School of Medicine |
Study Documents (Full-Text)
Additional Information:
| Responsible Party: | American Gastroenterological Association |
| ClinicalTrials.gov Identifier: | NCT03325855 |
| Other Study ID Numbers: |
AmericanGA |
| First Posted: | October 30, 2017 Key Record Dates |
| Last Update Posted: | February 17, 2023 |
| Last Verified: | October 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by American Gastroenterological Association:
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FMT CDI Fecal Matter Transplant |
Additional relevant MeSH terms:
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Clostridium Infections Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections |