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

MedStar Georgetown University Hospital
Georgetown, District of Columbia 20007
Contact:
Alyssa Graham

More Details

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.