Fecal Microbiota Transplant (FMT) National Registry

M
Monika Fischer, MD

Primary Investigator

Enrolling By Invitation
100 years or below
All
Phase N/A
10 participants needed
1 Location

Brief description of study

What is the purpose of this study?
This is 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. This registry will prospectively enroll 4,000 patients who undergo FMT at 75 sites throughout North America. This includes patients receiving FMT or other gut-related-microbiota products and the donors providing specimens for the enrolled patients’ FMT.  Patients will be enrolled regardless of race, gender, ethnicity, or age. 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.
 
Mission: To expand knowledge and optimize practice in the transplantation of fecal microbiota or other gut-related-microbiota products.
 
Goals: 
  1. To assess short-term and long-term safety
  2. To assess effectiveness
  3. To gather information on practice in North America.
  4. To promote scientific investigation
  5. To aid practitioners and sponsors in satisfying regulatory requirement
THIS STUDY IS ENROLLING BY INVITATION ONLY -  Participants who are being seen in clinical practice as an FMT recipient (or FMT donor) or as a recipient of other gut-related-microbiota products will be approached by the research team in a private room to receive information about the registry protocol, the option to participate in a biorepository sub-study, review the informed consent documents, and to ask questions and review the risks and benefits of participation.

Detailed description of study

What will happen during the study?
  • 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 of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Fecal Microbiota Transplant, FMT
  • Age: 100 years or below
  • Gender: All

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

Subject Exclusion Criteria
• Incarceration

 

Updated on 28 Apr 2025. Study ID: GI-AGA-FMT, 1712313128
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting referrals by invitation only