At a glance
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Fecal Microbiota Transplant in Veterans With Cirrhosis
In Brief
A Phase 2 clinical trial evaluating Fecal Microbial transplant Capsules, Fecal Microbial Transplant Enema, and 1 other intervention for Cirrhosis and Hepatic Encephalopathy. Completed, enrolled 60 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Oral capsules of FMT
FMT enema
Placebo