Fecal Microbiota Transplant National Registry

NCT ID: NCT03325855

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-20

Study Completion Date

2027-08-31

Brief Summary

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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

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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.

Conditions

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Fecal Microbiota Transplantation Clostridium Difficile Infection Gut Microbiome

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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None - Observational

None - Observational

Intervention Type OTHER

Other Intervention Names

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Observational

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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OpenBiome

INDUSTRY

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role collaborator

Loyola University Chicago

OTHER

Sponsor Role collaborator

Commure, Inc

UNKNOWN

Sponsor Role collaborator

American Gastroenterological Association

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gary D Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Co-Director, PennCHOP Microbiome Program

Colleen Kelly, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Loren Laine, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Phoenix Children's Hospital

Phoenix, Arizona, United States

Site Status WITHDRAWN

Children's Hospital of Los Angeles

Los Angeles, California, United States

Site Status ACTIVE_NOT_RECRUITING

University of California

Los Angeles, California, United States

Site Status WITHDRAWN

Stanford University

Redwood City, California, United States

Site Status RECRUITING

Sutter Roseville Medical Center

Roseville, California, United States

Site Status RECRUITING

University of California San Francisco

San Francisco, California, United States

Site Status RECRUITING

Ventura Clinical Trials

Ventura, California, United States

Site Status WITHDRAWN

Yale New Haven Hospital

Hamden, Connecticut, United States

Site Status RECRUITING

MedStar Georgetown University Hospital

Georgetown, District of Columbia, United States

Site Status ACTIVE_NOT_RECRUITING

Best Quality Research, Inc.

Hialeah, Florida, United States

Site Status WITHDRAWN

University of Miami, Miller School of Medicine

Miami, Florida, United States

Site Status RECRUITING

GI Pros

Naples, Florida, United States

Site Status WITHDRAWN

Emory University School of Medicine

Atlanta, Georgia, United States

Site Status RECRUITING

The University of Chicago

Chicago, Illinois, United States

Site Status RECRUITING

University of Chicago School of Medicine

Chicago, Illinois, United States

Site Status ACTIVE_NOT_RECRUITING

NorthShore University Health System

Evanston, Illinois, United States

Site Status TERMINATED

Loyola University Medical Center

Maywood, Illinois, United States

Site Status ACTIVE_NOT_RECRUITING

Loyola University of Chicago/ Loyola University Medical Center

Maywood, Illinois, United States

Site Status RECRUITING

Carle Foundation Hospital

Urbana, Illinois, United States

Site Status COMPLETED

Indiana University School of Medicine

Indianapolis, Indiana, United States

Site Status RECRUITING

University of Kansas Medical Center Research Institute

Kansas City, Kansas, United States

Site Status RECRUITING

Ochsner

New Orleans, Louisiana, United States

Site Status RECRUITING

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Site Status COMPLETED

American Gastroenterological Association

Bethesda, Maryland, United States

Site Status ACTIVE_NOT_RECRUITING

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

UMass Memorial Health

Worcester, Massachusetts, United States

Site Status RECRUITING

St. Joseph Mercy Hospital

Ann Arbor, Michigan, United States

Site Status COMPLETED

University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

Henry Ford Health Hospital

Detroit, Michigan, United States

Site Status RECRUITING

Mayo Clinic - Division of Pediatric Gastroenterology

Rochester, Minnesota, United States

Site Status RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Valley Hospital and Medical Center

Las Vegas, Nevada, United States

Site Status ACTIVE_NOT_RECRUITING

Atlantic Health System

Morristown, New Jersey, United States

Site Status COMPLETED

Rutgers

New Brunswick, New Jersey, United States

Site Status RECRUITING

Penn Medicine Princeton Health

Plainsboro, New Jersey, United States

Site Status NOT_YET_RECRUITING

Concorde Medical Group

New York, New York, United States

Site Status WITHDRAWN

New York University School of Medicine

New York, New York, United States

Site Status RECRUITING

Weill Cornell Medicine - Pediatric

New York, New York, United States

Site Status WITHDRAWN

Weill Cornell Medicine

New York, New York, United States

Site Status RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status RECRUITING

Gastroenterology Group of Rochester, LLP

Rochester, New York, United States

Site Status COMPLETED

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Oregon Health & Science University

Portland, Oregon, United States

Site Status RECRUITING

Temple University

Philadelphia, Pennsylvania, United States

Site Status ACTIVE_NOT_RECRUITING

Brown University Women's Medicine and Collaborative

Providence, Rhode Island, United States

Site Status ACTIVE_NOT_RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status ACTIVE_NOT_RECRUITING

Texas Children's Hospital / Baylor College of Medicine

Houston, Texas, United States

Site Status WITHDRAWN

Baylor Research Institute - Scott & White Medical Center

Temple, Texas, United States

Site Status COMPLETED

West Virginia University

Morgantown, West Virginia, United States

Site Status NOT_YET_RECRUITING

University of Wisconsin - Madison

Madison, Wisconsin, United States

Site Status RECRUITING

The Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status RECRUITING

University of Alberta

Edmonton, Alberta, Canada

Site Status WITHDRAWN

Countries

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United States Canada

Central Contacts

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Sonya Serra, MSc

Role: CONTACT

3019412616

Lydia Fredell, MA

Role: CONTACT

3019419797

Facility Contacts

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Tatiana Vidal

Role: primary

Rachael Delacruz

Role: primary

Candace Cotto, RN

Role: primary

Priscilla De Fatima Madero

Role: primary

Drew Siskin

Role: primary

Derrick Judkins

Role: primary

Dejan Micic, M.D.

Role: primary

Sarah Pardue Brennan, RN CCRP

Role: primary

Mollie Jackson, M.D.

Role: primary

James Gore, M.D.

Role: primary

Jenna Simes

Role: primary

Grace Hardwick

Role: primary

Anne Foley

Role: primary

Max Macgregor

Role: primary

El-Nachef, MD

Role: primary

Mary Manyara

Role: primary

Becky Hofschulte

Role: primary

Susan Cataldo

Role: primary

Sheryl Smolensky

Role: primary

Philip Dulock

Role: primary

Dominique Gay

Role: primary

Josephine Mitcham

Role: primary

Rachel Cooke

Role: primary

Melissa Hershman, M.D.

Role: primary

Asad Pervez, M.D.

Role: primary

Shelly Zimbric

Role: primary

Anita Ward

Role: primary

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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AmericanGA

Identifier Type: -

Identifier Source: org_study_id

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