# A randomized, placebo-controlled clinical trial examining the efficacy of Fecal Microbiota Transplantation (FMT) and subsequent dietary fiber in patients with moderate ulcerative colitis (MINDFUL)

> **NIH NIH R01** · WEILL MEDICAL COLL OF CORNELL UNIV · 2021 · $339,000

## Abstract

Ulcerative colitis (UC) is a chronic inflammatory disease of the intestine affecting over 1 million Americans.
Despite advances in medical therapies, nearly half of the patients requiring biologic medications will develop
medically refractory disease. As such, there is an urgent need for new treatment approaches for UC.
Emerging data from several randomized controlled trials (RCTs) suggest that fecal microbiota transplantation
(FMT) is safe and effective for the treatment of UC. Although extensive pre-clinical research showing a central
role for the gut microbiome in regulating animal models of colitis support these encouraging clinical findings,
variability in the efficacy of FMT for UC has limited the clinical impact. Research from our own group and
others has shown that the composition of the donor microbiome is associated with clinical response. Our
preliminary data extend these findings with strain level characterization showing that a core transferable
microbiota correlates with clinical response to FMT in UC. A detailed understanding of the mechanisms that
promote the transfer and engraftment of these beneficial bacteria is needed to enhance the clinical efficacy of
FMT for UC. Diet is a critical regulator of the intestinal microbiome and its subsequent impact on intestinal
inflammation, but the effect of diet and/or prebiotic supplementation on microbial engraftment and clinical
outcome following FMT has never been tested. It is, therefore, a critical need to assess the role for dietary
interventions in shaping the microbiome and clinical outcomes of FMT for UC. This proposal will evaluate the
fundamental hypothesis that dietary fiber supplementation can improve the clinical efficacy of FMT by shaping
microbial engraftment and function of specific transferable microbes. We propose the following aims to
evaluate this hypothesis: (i) to test the potential impact of fiber to improve clinical outcomes of FMT for UC with
a randomized, double-blind, placebo-controlled trial of FMT with or without open-label dietary fiber
supplementation for the treatment of mild to moderate UC; (ii) to define the impact of fiber supplementation on
microbial engraftment and immune cell function after FMT in patients with UC. If successful, our study will offer
critical support for the role of dietary fiber in shaping the outcome of FMT. Furthermore, our microbiome,
metabolomic, and immunologic characterization will provide key mechanistic analysis to support the design of
larger follow-up clinical studies. Given the feasibility and practicality of this intervention, results from this work
have the potential to transform FMT for UC as well as other indications.

## Key facts

- **NIH application ID:** 10183772
- **Project number:** 1R01DK128257-01
- **Recipient organization:** WEILL MEDICAL COLL OF CORNELL UNIV
- **Principal Investigator:** Randy S Longman
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $339,000
- **Award type:** 1
- **Project period:** 2021-04-06 → 2024-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10183772

## Citation

> US National Institutes of Health, RePORTER application 10183772, A randomized, placebo-controlled clinical trial examining the efficacy of Fecal Microbiota Transplantation (FMT) and subsequent dietary fiber in patients with moderate ulcerative colitis (MINDFUL) (1R01DK128257-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10183772. Licensed CC0.

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