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FMT: Fecal Microbiota Transplant National Registry

Sponsor
American Gastroenterological Association (Other)
Overall Status
Recruiting
CT.gov ID
NCT03325855
Collaborator
OpenBiome (Industry), University of California, San Diego (Other), Icahn School of Medicine at Mount Sinai (Other)
4,000
Enrollment
38
Locations
106.3
Anticipated Duration (Months)
105.3
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
4000 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Fecal Microbiota Transplant National Registry
Actual Study Start Date :
Sep 20, 2017
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2026

Outcome Measures

Primary Outcome Measures

  1. Occurrence of treatment related Adverse Events [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 [over 10 Years]

    Assess effectiveness of FMT by monitoring disease re-occurrence post treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's Hospital of Los Angeles Los Angeles California United States 90027
2 Stanford University Redwood City California United States 94063
3 Sutter Roseville Medical Center Roseville California United States 95661
4 University of California San Francisco San Francisco California United States 94115
5 Ventura Clinical Trials Ventura California United States 93003
6 Yale New Haven Hospital Hamden Connecticut United States 06518
7 MedStar Georgetown University Hospital Georgetown District of Columbia United States 20007
8 Best Quality Research, Inc. Hialeah Florida United States 33016
9 University of Miami, Miller School of Medicine Miami Florida United States 33136
10 GI Pros Naples Florida United States 34102
11 University of Chicago School of Medicine Chicago Illinois United States 60637
12 NorthShore University Health System Evanston Illinois United States 60201
13 Carle Foundation Hospital Urbana Illinois United States 61801
14 Indiana University School of Medicine Indianapolis Indiana United States 46202
15 Ochsner New Orleans Louisiana United States 70121
16 Johns Hopkins University School of Medicine Baltimore Maryland United States 21287
17 American Gastroenterological Association Bethesda Maryland United States 20814
18 Boston Children's Hospital Boston Massachusetts United States 02115
19 Brigham and Women's Hospital Boston Massachusetts United States 02115
20 St. Joseph Mercy Hospital Ann Arbor Michigan United States 48105
21 Mayo Clinic - Division of Pediatric Gastroenterology Rochester Minnesota United States 55905
22 Mayo Clinic Rochester Minnesota United States 55905
23 Atlantic Health System Morristown New Jersey United States 07960
24 Rutgers New Brunswick New Jersey United States 08901
25 Penn Medicine Princeton Health Plainsboro New Jersey United States 08536
26 Concorde Medical Group New York New York United States 10016
27 New York University School of Medicine New York New York United States 10016
28 Weill Cornell Medicine - Pediatric New York New York United States 10021
29 Weill Cornell Medicine New York New York United States 10021
30 Icahn School of Medicine at Mount Sinai New York New York United States 10029
31 Gastroenterology Group of Rochester, LLP Rochester New York United States 14618
32 Temple University Philadelphia Pennsylvania United States 19140
33 Brown University Women's Medicine and Collaborative Providence Rhode Island United States 02904
34 Vanderbilt University Medical Center Nashville Tennessee United States 37232
35 Texas Children's Hospital / Baylor College of Medicine Houston Texas United States 77030
36 Baylor Research Institute - Scott & White Medical Center Temple Texas United States 76508
37 University of Wisconsin - Madison Madison Wisconsin United States 53705
38 University of Alberta Edmonton Alberta Canada T6G2X8

Sponsors and Collaborators

  • American Gastroenterological Association
  • 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

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
American Gastroenterological Association
ClinicalTrials.gov Identifier:
NCT03325855
Other Study ID Numbers:
  • AmericanGA
First Posted:
Oct 30, 2017
Last Update Posted:
Mar 29, 2022
Last Verified:
Jul 1, 2021
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:
Clostridium Infections

Study Results

No Results Posted as of Mar 29, 2022