# Fecal Microbiome Transplant National Registry

> **NIH NIH R24** · AMERICAN GASTROENTEROLOGICAL ASSN/INST · 2020 · $701,629

## Abstract

Project Summary
Rapidly accumulating evidence suggests that modifying gut microbiota may promote health or treat disease, with
fecal microbiota transplantation (FMT) for C. difficile infection (CDI) being the first successful clinical application
of this concept. Given the rising incidence of CDI and the lack of effective therapies for recurrent CDI, the use of
FMT is growing rapidly, despite a paucity of clinical data and despite the theoretical risk that transfer of gut
microbiota may induce chronic diseases. The early adoption and expansion of FMT in clinical practice has
bypassed the standard investigatory pathway and preceded large randomized controlled trials that typically
evaluate efficacy and contribute important short- and long-term safety data. In order to overcome this deficit in
knowledge and experience, we propose to develop a national FMT registry. The goal of this proposal is to
collect clinical data from both FMT donors and recipients for the following purposes: 1) To assess short- and
long-term safety; 2) to gather information on practice in the U.S. and assess effectiveness of the
intervention; 3) to promote scientific investigation; and 4) to aid practitioners and trial sponsors in satisfying
regulatory requirements. This registry will prospectively enroll patients who undergo FMT at sites throughout the
U.S. Information on FMT methodology, FMT indication, as well as baseline data on donors and recipients will be
collected from each site. Patients will be followed at regular intervals for up to 10 years after FMT for pre-defined
and spontaneously reported adverse events and for pre-defined outcomes of effectiveness. The registry will
facilitate statistical analyses for signal detection, generation of descriptive data, and the conduct of comparative
effectiveness studies. A prospective cohort of 4,000 FMT patients will provide precise estimates of the incidence
of safety and effectiveness endpoints in real-world practice and rule out uncommon adverse events with high
confidence. This registry will link to an independent biobank that will collect, archive, and analyze approximately
3,000 fecal samples from the donors as well as recipients, providing a rich source for studying manipulation of
the gut microbiota in humans. The leadership of the American Gastroenterological Association (AGA) and its
partner organizations have worked together to develop the plans for this registry, which will be an extremely
important tool to assess short-term safety, identify potential long-term consequences, determine effectiveness
in real-world practice, help standardize best FMT practice, and gauge the potential consequences of
manipulating the gut microbiome in human health and disease.

## Key facts

- **NIH application ID:** 9981610
- **Project number:** 5R24AI118629-05
- **Recipient organization:** AMERICAN GASTROENTEROLOGICAL ASSN/INST
- **Principal Investigator:** Colleen Renee Kelly
- **Activity code:** R24 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $701,629
- **Award type:** 5
- **Project period:** 2016-08-04 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9981610

## Citation

> US National Institutes of Health, RePORTER application 9981610, Fecal Microbiome Transplant National Registry (5R24AI118629-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9981610. Licensed CC0.

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