drugset / Trial / NCT04155099
Investigational Microbiota Restoration Therapeutic for Hepatic Encephalopathy
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RBX7455 | Other / unclassified | 4 unknown | Oral |
| Subject | RBX7455 | Other / unclassified | 8 unknown | Oral |