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Purpose

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

Conditions

Eligibility

Eligible Ages
All ages
Eligible Genders
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

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Other
Time Perspective
Prospective

Recruiting Locations

Stanford University
Redwood City, California 94063

Sutter Roseville Medical Center
Roseville, California 95661
Contact:
Dawn Lenakakis, M.D.

University of California San Francisco
San Francisco, California 94115
Contact:
Rachael Delacruz

Yale New Haven Hospital
Hamden, Connecticut 06518
Contact:
Candace Cotto, RN

MedStar Georgetown University Hospital
Georgetown, District of Columbia 20007
Contact:
Teresa Truong

University of Miami, Miller School of Medicine
Miami, Florida 33136
Contact:
Priscilla De Fatima Madero

The University of Chicago
Chicago, Illinois 60637
Contact:
Derrick Judkins

University of Chicago School of Medicine
Chicago, Illinois 60637
Contact:
Kristi Kearney

Loyola University of Chicago/ Loyola University Medical Center
Maywood, Illinois 60153
Contact:
Ayokunle Abegunde, M.D.

Indiana University School of Medicine
Indianapolis, Indiana 46202
Contact:
Sarah Pardue Brennan, RN CCRP

University of Kansas Medical Center Research Institute
Kansas City, Kansas 66160
Contact:
Mollie Jackson, M.D.

Ochsner
New Orleans, Louisiana 70121
Contact:
James Gore, M.D.

Boston Children's Hospital
Boston, Massachusetts 02115
Contact:
Jenna Simes

Brigham and Women's Hospital
Boston, Massachusetts 02115
Contact:
Grace Hardwick

University of Michigan
Ann Arbor, Michigan 48109
Contact:
Max Macgregor

Mayo Clinic - Division of Pediatric Gastroenterology
Rochester, Minnesota 55905
Contact:
Mary Manyara

Mayo Clinic
Rochester, Minnesota 55905
Contact:
Becky Hofschulte

Valley Hospital and Medical Center
Las Vegas, Nevada 89146
Contact:
Vishvinder Sharma, MD

Atlantic Health System
Morristown, New Jersey 07960
Contact:
Stephanie Blash

Rutgers
New Brunswick, New Jersey 08901
Contact:
Susan Cataldo

New York University School of Medicine
New York, New York 10016
Contact:
Philip Dulock

Weill Cornell Medicine
New York, New York 10021
Contact:
Raymond Peterson

Icahn School of Medicine at Mount Sinai
New York, New York 10029
Contact:
Josephine Mitcham

University of North Carolina
Chapel Hill, North Carolina 27599
Contact:
Rachel Cooke

Oregon Health & Science University
Portland, Oregon 97239
Contact:
Melissa Hershman, M.D.

Temple University
Philadelphia, Pennsylvania 19140

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
Maribeth Nicholson

Baylor Research Institute - Scott & White Medical Center
Temple, Texas 76508
Contact:
Tamborie Moore

University of Wisconsin - Madison
Madison, Wisconsin 53705
Contact:
Amanda Young

The Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Contact:
Anita Ward

More Details

NCT ID
NCT03325855
Status
Recruiting
Sponsor
American Gastroenterological Association

Study Contact

Sonya Serra, MSc
3019412616
sserra@gastro.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center