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Summary

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

Fecal Microbiota Transplantation, Clostridium Difficile Infection, Gut Microbiome

Recruitment Status

Recruiting

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.

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

Intervention

Intervention Type

Intervention Name

Other

None - Observational

Gender

All

Min Age

N/A

Max Age

N/A

Download Date

March 29, 2022

Principal Investigator

N/A

Primary Contact Information

Sonya Serra, MSc

3019412616

sserra@gastro.org

Yanina Nersesova, MA

3019412600

ynersesova@gastro.org

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: