Fecal Microbiota Transplant National Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: None - Observational.
- Who it may be relevant to
- Registry conditions: Fecal Microbiota Transplantation, Clostridium Difficile Infection, Gut Microbiome. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other None - Observational
None - Observational
Primary outcome measures
- Occurrence of treatment related Adverse Events [Time frame: over 10 Years]
- Disease Re-occurrence Following FMT [Time frame: over 10 Years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 52 centers
- Phoenix Children's Hospital — Phoenix
- Children's Hospital of Los Angeles — Los Angeles
- University of California — Los Angeles
- Stanford University — Redwood City
- Sutter Roseville Medical Center — Roseville
- University of California San Francisco — San Francisco
- Ventura Clinical Trials — Ventura
- Yale New Haven Hospital — Hamden
- … and 44 more centers
Canada · 1 center
- University of Alberta — Edmonton
Identifiers
NCT: NCT03325855 · AmericanGA