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NCT03325855 Clinical Trial

Fecal Microbiota Transplant National Registry

Clostridium Difficile Infection Clinical Trial

— FMT  

Official title:
Fecal Microbiota Transplant National Registry

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03325855
Other study ID # AmericanGA
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 20, 2017
Est. completion date August 2027

Study information
Verified date January 2024
Source American Gastroenterological Association
Contact Sonya Serra, MSc
Phone 3019412616
Email sserra@gastro.org
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 4000
Est. completion date August 2027
Est. primary completion date August 2027
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• None - Observational
None - Observational

Locations
Country Name City State
Canada University of Alberta Edmonton Alberta
United States St. Joseph Mercy Hospital Ann Arbor Michigan
United States University of Michigan Ann Arbor Michigan
United States Johns Hopkins University School of Medicine Baltimore Maryland
United States American Gastroenterological Association Bethesda Maryland
United States Boston Children's Hospital Boston Massachusetts
United States Brigham and Women's Hospital Boston Massachusetts
United States University of North Carolina Chapel Hill North Carolina
United States The University of Chicago Chicago Illinois
United States University of Chicago School of Medicine Chicago Illinois
United States NorthShore University Health System Evanston Illinois
United States MedStar Georgetown University Hospital Georgetown District of Columbia
United States Yale New Haven Hospital Hamden Connecticut
United States Best Quality Research, Inc. Hialeah Florida
United States Texas Children's Hospital / Baylor College of Medicine Houston Texas
United States Indiana University School of Medicine Indianapolis Indiana
United States University of Kansas Medical Center Research Institute Kansas City Kansas
United States Valley Hospital and Medical Center Las Vegas Nevada
United States Children's Hospital of Los Angeles Los Angeles California
United States University of California Los Angeles California
United States University of Wisconsin - Madison Madison Wisconsin
United States Loyola University of Chicago/ Loyola University Medical Center Maywood Illinois
United States University of Miami, Miller School of Medicine Miami Florida
United States The Medical College of Wisconsin Milwaukee Wisconsin
United States West Virginia University Morgantown West Virginia
United States Atlantic Health System Morristown New Jersey
United States GI Pros Naples Florida
United States Vanderbilt University Medical Center Nashville Tennessee
United States Rutgers New Brunswick New Jersey
United States Ochsner New Orleans Louisiana
United States Concorde Medical Group New York New York
United States Icahn School of Medicine at Mount Sinai New York New York
United States New York University School of Medicine New York New York
United States Weill Cornell Medicine New York New York
United States Weill Cornell Medicine - Pediatric New York New York
United States Temple University Philadelphia Pennsylvania
United States Phoenix Children's Hospital Phoenix Arizona
United States Penn Medicine Princeton Health Plainsboro New Jersey
United States Oregon Health & Science University Portland Oregon
United States Brown University Women's Medicine and Collaborative Providence Rhode Island
United States Stanford University Redwood City California
United States Gastroenterology Group of Rochester, LLP Rochester New York
United States Mayo Clinic Rochester Minnesota
United States Mayo Clinic - Division of Pediatric Gastroenterology Rochester Minnesota
United States Sutter Roseville Medical Center Roseville California
United States University of California San Francisco San Francisco California
United States Baylor Research Institute - Scott & White Medical Center Temple Texas
United States Carle Foundation Hospital Urbana Illinois
United States Ventura Clinical Trials Ventura California

Sponsors (7)
Lead Sponsor Collaborator
American Gastroenterological Association Loyola University Chicago, OpenBiome, RX.Health Inc., University of California, San Diego, University of Minnesota, University of Pennsylvania

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Occurrence of treatment related Adverse Events Adverse events to be monitored include surgeries, infection, hospitalization, other life-threatening events, death and newly diagnosed diseases. over 10 Years
Primary Disease Re-occurrence Following FMT Assess effectiveness of FMT by monitoring disease re-occurrence post treatment. over 10 Years
See also
  Status Clinical Trial Phase
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Not yet recruiting NCT03586206 - Relationship Between C. Difficile Toxins' Serum Level With C. Difficile Infection
Suspended NCT03350711 - A Screening and Recruitment Study in Adults Expressing Interest in the Emory Microbiota Enrichment Program
Withdrawn NCT03643887 - Phase II Trial of Fecal Microbiota Transplant (FMT) for VRE and CRE Patients Phase 2
Terminated NCT04000555 - Oral Vancomycin for Secondary Prophylaxis of Clostridium Difficile Infection (CDI) Phase 4
Terminated NCT03065374 - Treatment for Clostridium-difficile Infection With IMM529 Phase 1/Phase 2
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Completed NCT04075422 - Bezlotoxumab - in "Real Life" - During the First Episode of Clostridium Difficile Infection in Patients With High Risk of Recurrence.
Recruiting NCT03712722 - Fecal Microbiota Transplantation (FMT) for Clostridium Difficile
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Completed NCT02951702 - Oral Vancomyin for Primary Clostridium Difficile Infection Prophylaxis in Patients Receiving High-Risk Antibiotics Phase 4