Oral fecal transplant for alcohol-related cirrhosis
Official title: Fecal microbiota transplant for Alcohol-Associated Cirrhosis
Funded at Virginia Commonwealth University · NIH-11145716 · Data updated 2026-11-12
This trial gives capsules of healthy donor gut bacteria to people with alcohol use disorder and cirrhosis to try to reduce drinking, cravings, and improve thinking and liver and overall health.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Virginia Commonwealth University NIH-funded |
| Lab location | 1 site (Richmond, United States) |
| Project start | September 12, 2022 |
| Project end | August 31, 2027 |
| Funding year | 2025 |
| Award (this year) | $614,842 |
| NIH project number | 5R01AA029398-04 |
| Project ID | NIH-11145716 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults with alcohol use disorder who also have cirrhosis and who can attend treatment and follow-up visits at the study site are the intended participants.
✕Less likely to help
People without alcohol use disorder or without cirrhosis, or those unable to travel to the study center, are unlikely to benefit from or be eligible for this trial.
What this research studies
If you join, you'll be randomly assigned to receive either capsules of freeze-dried donor fecal microbiota or matching placebo at the start and again at day 30, and neither you nor the study team will know which you get. The capsules are made under Good Manufacturing Practices and the team has tested similar FMT products before. Researchers will follow your alcohol use, cravings, cognition, psychosocial quality of life, and liver-related measures over time. This is a Phase 1b/2a double-blind, placebo-controlled trial run at Virginia Commonwealth University.
Why it matters
Potential benefit: If successful, reshaping gut bacteria could lower drinking and cravings, improve thinking and quality of life, and reduce liver-related harms in people with alcohol-associated cirrhosis.
How similar studies have gone: Previous randomized trials by this group showed that FMT reduced alcohol consumption and cravings and improved cognition and quality of life in cirrhotic patients, though larger confirmatory trials are needed.
Where this research is happening
-
Virginia Commonwealth University
Richmond, United States Active
Researchers
- Principal investigator: Bajaj, Jasmohan S — Virginia Commonwealth University
- Study coordinator: Bajaj, Jasmohan S
Related research
Other NIH-funded projects on the same topics.
-
Fecal transplant to help alcohol-related liver disease
A clinical trial will test whether a standardized oral fecal microbiota transplant (FMT) capsule can help people with alcohol-related liver disease drink less and feel mentally better.
-
Microbiota Transplant Therapy to Prevent HE Recurrence in Veterans with Cirrhosis
A Phase 2B multi-center study tests using donor microbiota transplants to prevent hepatic encephalopathy from coming back in Veterans with cirrhosis.
-
Using fecal microbiota transplant to treat alcohol-related liver disease
This study is looking at whether a special treatment using gut bacteria from healthy donors can help people with liver damage from alcohol by reducing their cravings for alcohol and improving their health.
-
Vaginal microbiota transplant to promote Lactobacillus-dominant cervicovaginal communities
A clinical trial tests whether transferring vaginal microbiota from healthy donors can establish Lactobacillus-dominant vaginal communities to reduce risks linked with bacterial vaginosis.
-
National Fecal Microbiota Transplant (FMT) Registry
This registry collects health and safety information from people who receive fecal microbiota transplants or related live-microbe treatments to help patients with recurrent or severe C. difficile infection.
-
Gut Restore-PAH: Microbiota Transplant to Help Pulmonary Angiopathy
A small pilot study will test whether transplanting healthy gut bacteria, with antibiotics beforehand and fiber support, can help people with pulmonary arterial hypertension.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.