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NCT03325855Recruiting

Fecal Microbiota Transplant National Registry

American Gastroenterological Association

Start Date

9/20/2017

Completion Date

8/1/2027

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

Age Range: No minimum to No maximum

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

Interventions

OTHER

None - Observational

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Conditions

Fecal Microbiota TransplantationClostridium Difficile InfectionGut Microbiome

Locations

Phoenix Children's Hospital

Phoenix, Arizona 85016

United States

Children's Hospital of Los Angeles

Los Angeles, California 90027

United States

University of California

Los Angeles, California 90095

United States

Stanford University

Redwood City, California 94063

United States

Sutter Roseville Medical Center

Roseville, California 95661

United States

University of California San Francisco

San Francisco, California 94115

United States

Ventura Clinical Trials

Ventura, California 93003

United States

Yale New Haven Hospital

Hamden, Connecticut 06518

United States

MedStar Georgetown University Hospital

Georgetown, District of Columbia 20007

United States

Best Quality Research, Inc.

Hialeah, Florida 33016

United States

University of Miami, Miller School of Medicine

Miami, Florida 33136

United States

GI Pros

Naples, Florida 34102

United States

Emory University School of Medicine

Atlanta, Georgia 30307

United States

The University of Chicago

Chicago, Illinois 60637

United States

University of Chicago School of Medicine

Chicago, Illinois 60637

United States

NorthShore University Health System

Evanston, Illinois 60201

United States

Loyola University Medical Center

Maywood, Illinois 60153

United States

Loyola University of Chicago/ Loyola University Medical Center

Maywood, Illinois 60153

United States

Carle Foundation Hospital

Urbana, Illinois 61801

United States

Indiana University School of Medicine

Indianapolis, Indiana 46202

United States

University of Kansas Medical Center Research Institute

Kansas City, Kansas 66160

United States

Ochsner

New Orleans, Louisiana 70121

United States

Johns Hopkins University School of Medicine

Baltimore, Maryland 21287

United States

American Gastroenterological Association

Bethesda, Maryland 20814

United States

Boston Children's Hospital

Boston, Massachusetts 02115

United States

Brigham and Women's Hospital

Boston, Massachusetts 02115

United States

UMass Memorial Health

Worcester, Massachusetts 01604

United States

St. Joseph Mercy Hospital

Ann Arbor, Michigan 48105

United States

University of Michigan

Ann Arbor, Michigan 48109

United States

Henry Ford Health Hospital

Detroit, Michigan 48202

United States

Mayo Clinic - Division of Pediatric Gastroenterology

Rochester, Minnesota 55905

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

Valley Hospital and Medical Center

Las Vegas, Nevada 89146

United States

Atlantic Health System

Morristown, New Jersey 07960

United States

Rutgers

New Brunswick, New Jersey 08901

United States

Penn Medicine Princeton Health

Plainsboro, New Jersey 08536

United States

Concorde Medical Group

New York, New York 10016

United States

New York University School of Medicine

New York, New York 10016

United States

Weill Cornell Medicine - Pediatric

New York, New York 10021

United States

Weill Cornell Medicine

New York, New York 10021

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

Gastroenterology Group of Rochester, LLP

Rochester, New York 14618

United States

University of North Carolina

Chapel Hill, North Carolina 27599

United States

Oregon Health & Science University

Portland, Oregon 97239

United States

Temple University

Philadelphia, Pennsylvania 19140

United States

Brown University Women's Medicine and Collaborative

Providence, Rhode Island 02904

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

Texas Children's Hospital / Baylor College of Medicine

Houston, Texas 77030

United States

Baylor Research Institute - Scott & White Medical Center

Temple, Texas 76508

United States

West Virginia University

Morgantown, West Virginia 26506

United States

University of Wisconsin - Madison

Madison, Wisconsin 53705

United States

The Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

University of Alberta

Edmonton, Alberta T6G2X8

Canada