Microbiota Transplant Therapy to Prevent HE Recurrence in Veterans with Cirrhosis
Official title: Microbiota Transplant Therapy to Prevent HE recurrence in a Phase 2B Multi-Center Trial of Veterans with Cirrhosis
Funded at VA Veterans Administration Hospital · NIH-11299678 · Data updated 2026-11-12
A Phase 2B multi-center study tests using donor microbiota transplants to prevent hepatic encephalopathy from coming back in Veterans with cirrhosis.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | VA Veterans Administration Hospital NIH-funded |
| Lab location | 1 site (Richmond, United States) |
| Project start | October 1, 2026 |
| Project end | September 30, 2030 |
| Funding year | 2027 |
| NIH project number | 1I01RD001314-01 |
| Project ID | NIH-11299678 on NIH RePORTER |
Who could benefit from this research
✓Could help
Veterans with cirrhosis who have experienced recurrent hepatic encephalopathy and meet study eligibility.
✕Less likely to help
Patients without recurrent HE or who do not meet eligibility criteria may not benefit from this intervention.
What this research studies
This trial will use microbiota transplant therapy (MTT) from carefully selected donors to reduce recurrent hepatic encephalopathy in Veterans with cirrhosis. It builds on prior safety and feasibility data and expands to multiple centers, with a home-based, shelf-stable treatment approach to improve accessibility. The study design includes flexible visit options and consideration of rifaximin use to better tailor treatment for participants. Patients would be followed for HE recurrence, hospital readmissions, and quality-of-life impacts to determine whether MTT can break the cycle of relapse.
Why it matters
Potential benefit: If successful, this therapy could reduce HE flares, hospitalizations, and the overall burden of cirrhosis for Veterans.
How similar studies have gone: Previous early-phase trials showed safety and favorable microbiota changes, supporting expansion to a multicenter evaluation.
Where this research is happening
-
VA Veterans Administration Hospital
Richmond, United States Active
Researchers
- Principal investigator: Bajaj, Jasmohan S — VA Veterans Administration Hospital
- Study coordinator: Bajaj, Jasmohan S
Related research
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-
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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.