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NCT04155099 · ClinicalTrials.gov registry record · Phase 2
Investigational Microbiota Restoration Therapeutic for Hepatic Encephalopathy
A Phase 2 study, sponsored by Ochsner Health System.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT04155099: Clinical Trial Phase 2 study, sponsored by Ochsner Health System.
NCT04155099 is a Phase 2 study that was terminated before completion, run by Ochsner Health System. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04155099, a Phase 2 study, was terminated before completion, sponsored by Ochsner Health System.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study 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.
Primary Outcome
Determine whether microbiota restoration therapy improves cognition 1 month after treatment by measuring differences in time scores from EncephalApp. The app times participants in seconds (s) in variations of the Stroop Test. The average (s) across all trials will be reported as well as the difference in (s) between (trial 1)-(trial 5). Longer completion times indicate greater cognitive impairment, while a decrease in completion time from trial 1 to trial 5 indicates learning (cognitive improvem
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL RBX7455
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2021-03-01 |
| Est. Completion | 2023-07-30 |
| Phase | Phase 2 |
Why NCT04155099 stopped before completion
NCT04155099 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04155099 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04155099 about?
NCT04155099 is a clinical study titled "Investigational Microbiota Restoration Therapeutic for Hepatic Encephalopathy". 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...
What is the current status of trial NCT04155099?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2021-03-01. Estimated completion is 2023-07-30.
What interventions are being tested in trial NCT04155099?
The interventions under investigation include: Placebo (BIOLOGICAL), RBX7455 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04155099?
This trial is sponsored by Ochsner Health System, which has 29 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04155099's enrollment target sits among peer trials
5 2000th of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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