# Clinical trial exploring the diet-microbiome axis in allo-HCT patients

> **NIH NIH P01** · UNIVERSITY OF MICHIGAN AT ANN ARBOR · 2021 · $450,069

## Abstract

PROJECT SUMMARY/ABSTRACT – PROJECT 4
Allogeneic hematopoietic stem cell transplantation (allo-HCT) is a potent form of cellular therapy that
has the potential to cure malignant and benign hematological conditions. However, its utility is limited
by the development of graft-versus-host disease (GVHD). GI GVHD is the principal cause of non-
relapse mortality (NRM) after allo-HCT. Recent evidence has brought into focus the role played by the
metabolites derived from host-microbiota interactions in the severity of GI GVHD. However, the
biological mechanisms, clinical feasibility, and the impact of altering the GI microbial metabolites on GI
GVHD remain unknown. Project 4 will focus on dietary manipulation of the microbiome-metabolomic
axis via dietary supplementation with resistant potato starch (RPS) for mitigating GVHD in allo-HCT
patients. This project encompasses an investigator initiated proof-of-concept clinical trial that has been
developed to translate the preliminary data generated from Projects 1 and 3. This trial is being
performed under an IND from the FDA. It includes serial biosample (stool and plasma) collection and
analyses for the microbiota and metabolite alterations, informed by mechanistic studies from projects 1,
2, and 3. We will also combine these data with longitudinal measurement of molecules reflecting
intestinal epithelial injury, collectively comprising discovery approaches to more comprehensively study
the effects of RPS on the microbiome, its dependent metabolites and host in allo-HCT patients.

## Key facts

- **NIH application ID:** 10241908
- **Project number:** 5P01HL149633-02
- **Recipient organization:** UNIVERSITY OF MICHIGAN AT ANN ARBOR
- **Principal Investigator:** MUNEESH TEWARI
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $450,069
- **Award type:** 5
- **Project period:** 2020-09-01 → 2025-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10241908

## Citation

> US National Institutes of Health, RePORTER application 10241908, Clinical trial exploring the diet-microbiome axis in allo-HCT patients (5P01HL149633-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10241908. Licensed CC0.

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