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NCT03796598 · ClinicalTrials.gov registry record · Phase 1
FMT in Cirrhosis and Hepatic Encephalopathy
A Phase 1 study of Cirrhosis and Hepatic Encephalopathy, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT03796598: Completed Phase 1 study of Cirrhosis and Hepatic Encephalopathy, sponsored by VA Office of Research and Development.
NCT03796598 is a Phase 1 study of Cirrhosis and Hepatic Encephalopathy that has completed, run by VA Office of Research and Development. The registered enrollment target is 60 participants, below the 90,408-participant average among 53 other Cirrhosis trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03796598, a Phase 1 study of Cirrhosis and Hepatic Encephalopathy, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Number of patients with serious adverse events between groups related to FMT, especially related to HE
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Fecal Microbial transplant Capsules
- DRUG Fecal Microbial Transplant Enema
Study Locations (1)
Virginia
- Hunter Holmes McGuire VA Medical Center, Richmond, VA - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2019-07-29 |
| Est. Completion | 2023-12-20 |
| Phase | Phase 1 |
What the finished NCT03796598 record still lists
NCT03796598 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 90,408-participant average among 53 other Cirrhosis trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Cirrhosis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03796598 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT03796598 about?
NCT03796598 is a clinical study titled "FMT in Cirrhosis and Hepatic Encephalopathy". 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 f...
What is the current status of trial NCT03796598?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2019-07-29. Estimated completion is 2023-12-20.
What conditions does trial NCT03796598 study?
This clinical trial studies the following conditions: Cirrhosis, Hepatic Encephalopathy.
What interventions are being tested in trial NCT03796598?
The interventions under investigation include: Placebo (OTHER), Fecal Microbial transplant Capsules (DRUG), Fecal Microbial Transplant Enema (DRUG).
Who is sponsoring clinical trial NCT03796598?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03796598 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cirrhosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03796598's enrollment target sits among peer trials
60 23rd of 53 higher than 30 of 53 other Cirrhosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cirrhosis 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.
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