Clinical trial NCT03325855: Fecal Microbiota Transplant National Registry
Official title: Fecal Microbiota Transplant National Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fecal Microbiota Transplantation
Clostridium Difficile Infection
Gut Microbiome
Keywords: FMT
CDI
Fecal Matter Transplant
Lead sponsor: American Gastroenterological Association
Sponsor class: OTHER
Collaborators: name: OpenBiome
name: University of California, San Diego
name: Commure
name: University of Pennsylvania
name: University of Minnesota
name: Loyola University Chicago
First posted: 2017-10-30
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Occurrence of treatment related Adverse Events
timeFrame: over 10 Years
measure: Disease Re-occurrence Following FMT
timeFrame: over 10 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: Los Angeles
country: United States
facility: University of California
state: California
city: Redwood City
country: United States
facility: Stanford University
state: California
city: Roseville
country: United States
facility: Sutter Roseville Medical Center
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Ventura
country: United States
facility: Ventura Clinical Trials
state: California
city: Hamden
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Georgetown
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Hialeah
country: United States
facility: Best Quality Research, Inc.
state: Florida
city: Miami
country: United States
facility: University of Miami, Miller School of Medicine
state: Florida
city: Naples
country: United States
facility: GI Pros
state: Florida
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Chicago
country: United States
facility: University of Chicago School of Medicine
state: Illinois
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Maywood
country: United States
facility: Loyola University of Chicago/ Loyola University Medical Center
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center Research Institute
state: Kansas
city: New Orleans
country: United States
facility: Ochsner
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Bethesda
country: United States
facility: American Gastroenterological Association
state: Maryland
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: St. Joseph Mercy Hospital
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Division of Pediatric Gastroenterology
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Las Vegas
country: United States
facility: Valley Hospital and Medical Center
state: Nevada
city: Morristown
country: United States
facility: Atlantic Health System
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers
state: New Jersey
city: Plainsboro
country: United States
facility: Penn Medicine Princeton Health
state: New Jersey
city: New York
country: United States
facility: Concorde Medical Group
state: New York
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine - Pediatric
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Rochester
country: United States
facility: Gastroenterology Group of Rochester, LLP
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Providence
country: United States
facility: Brown University Women's Medicine and Collaborative
state: Rhode Island
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Texas Children's Hospital / Baylor College of Medicine
state: Texas
city: Temple
country: United States
facility: Baylor Research Institute - Scott & White Medical Center
state: Texas
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
city: Milwaukee
country: United States
facility: The Medical College of Wisconsin
state: Wisconsin
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: Co-Director, PennCHOP Microbiome Program
name: Gary D Wu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Colleen Kelly, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Loren Laine, MD
role: PRINCIPAL_INVESTIGATOR
References: