drugset / Trial / NCT04155099

Investigational Microbiota Restoration Therapeutic for Hepatic Encephalopathy

NCT04155099 ↗

Phase 2 Terminated 5 enrolled Ochsner Health System Rebiotix Inc. · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

Individuals with cirrhosis are likely to develop overt hepatic encephalopathy for which diagnostic modalities and treatment options are limited. The purpose of this study is to determine if individuals with cirrhosis who experience hepatic encephalopathy would benefit from investigational microbiota restoration therapy due to their inherent cognitive alterations. Analysis for a correlation between changes in microbiome composition and specific blood biomarkers could allow for earlier diagnosis of HE which could then be treated earlier and with novel treatments.

Timeline

Start
2021-03-01
Primary completion
2023-07-30
Completion
2023-07-30

Outcome

Outcome not reported

Stopped (Enrollment): “Unable to recruit participants”

Drugs

EvaluationDrugModalityDoseRoute
Subject RBX7455 Other / unclassified 4 unknown Oral
Subject RBX7455 Other / unclassified 8 unknown Oral