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Fecal Microbiota Transplant National Registry (FMT)

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ClinicalTrials.gov Identifier: NCT03325855
Recruitment Status : Recruiting
First Posted : October 30, 2017
Last Update Posted : March 25, 2019
Sponsor:
Collaborators:
OpenBiome
University of California, San Diego
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
American Gastroenterological Association

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

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.

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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 2021
Estimated Study Completion Date : August 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement


Intervention Details:
  • Other: None - Observational
    None - Observational
    Other Name: Observational


Primary Outcome Measures :
  1. 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.

  2. 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:

  • 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

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
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Contact: Sonya Serra, MSc 3019412616 sserra@gastro.org
Contact: Yanina Nersesova, MA 3019412600 ynersesova@gastro.org

  Show 24 Study Locations
Sponsors and Collaborators
American Gastroenterological Association
OpenBiome
University of California, San Diego
Icahn School of Medicine at Mount Sinai
  Study Documents (Full-Text)

Documents provided by American Gastroenterological Association:
Study Protocol  [PDF] June 20, 2017


Additional Information:

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Responsible Party: American Gastroenterological Association
ClinicalTrials.gov Identifier: NCT03325855     History of Changes
Other Study ID Numbers: AmericanGA
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by American Gastroenterological Association:
FMT
CDI
Fecal Matter Transplant

Additional relevant MeSH terms:
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Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections