# Evaluation of oral administration of PRIM-DJ2727 capsule containing microbiota suspension in patients with severe alcoholic hepatitis:  An Open-Label Study

> **NIH NIH R21** · BAYLOR COLLEGE OF MEDICINE · 2022 · $190,000

## Abstract

Alcoholic hepatitis (AH) is a major public health problem in the United States, in which 30-50% die within the
first 28 days. For the past few decades, steroid therapy has been the standard treatment in managing patients
with severe AH, however, it hasn’t significantly improved survival rates among these patients. Moreover,
shortage of organs and cost for liver transplantation are major barriers for liver transplantation in patients with
AH. There is growing evidence suggesting the role of the gut-liver axis in alcohol-induced tissue injury and liver
failure among heavy alcohol drinkers. The gut microbial community of patients with advanced alcoholic liver
diseases is known to be dysbiotic. Therefore, microbiome-directed therapy that can complement microbial
deficiencies in patients with AH may reduce complications of the diseases. Furthermore, over the last few years,
multiple studies have shown that fecal microbiome transplant (FMT) is a safe and more effective approach in
treatment of liver cirrhosis and recurrent encephalopathy. A recent study by Indian investigators showed that
modulation of intestinal microbiota has shown to improve survival in patients with severe AH. However, the
study faced some limitations including: limited longitudinal assessment of the prognostic scores for alcoholic
hepatitis, use of nasoduodenal tube to deliver fecal microbiome, and lack of detail in profiling of intestinal
microbiome. In this proposed clinical trial, we hypothesize that FMT in patients with severe AH will be safe and
will result in improvement of intestinal microbiome diversity which might contribute to improvement of
biochemical parameters, prognostic scores, and clinical outcome of the patients. To test this hypothesis, we
propose recruiting 12 patients with severe AH to participate in a single center trial using the Simon’s two-stage,
minimax design in which microbiome suspension containing capsules, called PRIM-DJ2727 will be
administered. The aims of this pilot study are as follows: 1) To explore the impact of FMT in improving the clinical
outcome of 12 patients with severe AH. Eligible patients will receive 10 does of PRIM-DJ2727 (30 grams/day)
for a week followed by once weekly for 3 weeks. We plan to assess FMT-response rate based on Lille score and
changes in biochemical parameters, prognostic scores, and overall survival. 2) To characterize gut microbiome
diversity associated with severe alcoholic hepatitis patients at several time points during and post-FMT; this will
be done through analyzing stool samples using whole genome sequencing at weeks (1 & 4) and at months (3 &
6). Despite no evidence to support severe adverse effects for FMT administration in patients with liver diseases,
we aimed to monitor the study participants for treatment safety. This proposed study may have a major impact
on the field of hepatology. It will shed the light on the potential use of FMT as a safe, effective and affordable tool
in managing patients with se...

## Key facts

- **NIH application ID:** 10527603
- **Project number:** 1R21AA029511-01A1
- **Recipient organization:** BAYLOR COLLEGE OF MEDICINE
- **Principal Investigator:** Prasun Kumar Jalal
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $190,000
- **Award type:** 1
- **Project period:** 2022-08-18 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10527603

## Citation

> US National Institutes of Health, RePORTER application 10527603, Evaluation of oral administration of PRIM-DJ2727 capsule containing microbiota suspension in patients with severe alcoholic hepatitis:  An Open-Label Study (1R21AA029511-01A1). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10527603. Licensed CC0.

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