FMT in Cirrhosis and Hepatic Encephalopathy

Summary

Patients with end stage of liver disease or cirrhosis can develop confusion due to high ammonia and inflammation. This confusion is brought upon by changes in the bacteria in the bowels and may not respond to current standard of care treatments. Repeated episodes of confusion can make it difficult for patients to function and may result in multiple admissions to the hospital and burden on the family. The investigators have studied using a healthy person's stool to replace the bowel bacteria, called fecal microbial transplant, in small studies with good results. In this trial the investigators propose to perform these procedures using an upper and lower route in Veterans who suffer from this condition and follow them for safety and HE and related hospitalizations over 6 months. The investigators will compare this to placebo treatments and hope that this intervention can improve the health and daily functioning of affected patients.

Timeline

Start

2019-07-29

Primary completion

2023-12-19

Completion

2023-12-20

Publications

• Bajaj JS, Fagan A, Sterling RK, Sikaroodi M, Gallagher ML, Lee H, Matherly SC, Bartels A, Mousel T, Davis BC, Puri P, Fuchs M, Thacker LR, McGinley JP, Khoruts A, Gillevet PM. The multi-omic basis for hepatic encephalopathy recurrence: Analysis of the THEMATIC trial. JHEP Rep. 2025 Oct 18;8(1):101634. doi: 10.1016/j.jhepr.2025.101634. eCollection 2026 Jan.
• Bloom PP, Bajaj JS. The Current and Future State of Microbiome Therapeutics in Liver Disease. Am J Gastroenterol. 2024 Jan 1;119(1S):S36-S41. doi: 10.14309/ajg.0000000000002581. No abstract available.

Drugs

Indications