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Trial record 1 of 2 for:    FMT National registry
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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 : May 15, 2020
Sponsor:
Collaborators:
OpenBiome
University of California, San Diego
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
American Gastroenterological Association

Tracking Information
First Submitted Date October 17, 2017
First Posted Date October 30, 2017
Last Update Posted Date May 15, 2020
Actual Study Start Date September 20, 2017
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 27, 2017)
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Fecal Microbiota Transplant National Registry
Official Title Fecal Microbiota Transplant National Registry
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
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 Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 10 Years
Biospecimen Not Provided
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.
Condition
  • Fecal Microbiota Transplantation
  • Clostridium Difficile Infection
  • Gut Microbiome
Intervention Other: None - Observational
None - Observational
Other Name: Observational
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 27, 2017)
4000
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2026
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Sonya Serra, MSc 3019412616 sserra@gastro.org
Contact: Yanina Nersesova, MA 3019412600 ynersesova@gastro.org
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03325855
Other Study ID Numbers AmericanGA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party American Gastroenterological Association
Study Sponsor American Gastroenterological Association
Collaborators
  • OpenBiome
  • University of California, San Diego
  • Icahn School of Medicine at Mount Sinai
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
PRS Account American Gastroenterological Association
Verification Date April 2020