# The Saint Louis University Component of the NASH CRN

> **NIH NIH U01** · SAINT LOUIS UNIVERSITY · 2022 · $478,252

## Abstract

Abstract
This application is for the Continuation of the Nonalcoholic Steatohepatitis Clinical Research Network (NASH
CRN) clinical center at Saint Louis University and its pediatric component at Baylor University. The NASH
Clinical Research Network (NASH CRN) has been sponsored by the NIDDK since 2002 with renewals in 2009
and 2014. Nonalcoholic fatty liver disease (NAFLD) affects more than one out of three adults and one out of
five children the U.S. NAFLD, and especially its most severe subset nonalcoholic steatohepatitis (NASH), may
lead to cirrhosis and primary liver cancer resulting in death or liver transplant and substantial health burdens
and costs. The NASH CRN is ideally and uniquely positioned to impact the growing public health significance
of NASH that can only be addressed via a large research consortium. The primary objective of the NASH CRN
is to perform clinical trials of therapeutic agents for NASH and NAFLD in adults and children. A closely linked
and high priority secondary objective is to conduct translational research in NASH and NAFLD focusing on the
pathogenesis that will provide the basis for understanding the natural history and developing means of better
diagnosis, prevention, treatment, and clinical management. In the next phase of the NASH CRN, the adult and
pediatric therapeutic trials initiated during the previous funding cycles will be completed and new therapeutic
trials, including phase 2a proof of mechanism and phase 2b clinical trials will be initiated to develop evidence-
based treatment options that are safe, effective, simple, cost-effective and broadly applicable. The longitudinal
cohort of adults and children with NAFLD collected over the past decade will be extended to prospectively
define the natural history of the disease, the cardiovascular and metabolic risk factors, and will aid in biomarker
discovery and validation. This cohort will also facilitate the development and validation of non-invasive
techniques to identify those with NASH, predict who will respond to treatments, and identify factors affecting
disease progression. The treatment trial proposed in this application is a phase 2a trial of a dietary supplement
called tributyrin. Tributyrin makes up about 3% of butter and is a prodrug of butyric acid. Butyric acid is an
important metabolite produced by bacteria in the GI tract during their normal metabolism of dietary fiber.
Butyric acid has been shown to be the primary energy source for the layer of cells that line the colon where it
promotes the function of these cells and prevents harmful bacterial products from entering the blood and
damaging the liver. It has also been found to have beneficial effects on metabolism throughout the body.
Animal data supports the rationale for studying butyric acid, or its precursor tributyrin, in treating NASH but
human data are very limited. Additional translational studies are proposed in this application to mechanistically
understand the benefits of tribu...

## Key facts

- **NIH application ID:** 10451753
- **Project number:** 5U01DK061718-21
- **Recipient organization:** SAINT LOUIS UNIVERSITY
- **Principal Investigator:** BRENT A NEUSCHWANDER-TETRI
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $478,252
- **Award type:** 5
- **Project period:** 2002-05-20 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10451753

## Citation

> US National Institutes of Health, RePORTER application 10451753, The Saint Louis University Component of the NASH CRN (5U01DK061718-21). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/10451753. Licensed CC0.

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