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NCT03416751 · ClinicalTrials.gov registry record · Phase 1
Fecal Microbial Transplant for Alcohol Misuse in Cirrhosis
A Phase 1 study, sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT03416751 is a Phase 1 study that has completed, run by Hunter Holmes Mcguire Veteran Affairs Medical Center. The registered enrollment target is 20 participants.
The verdict
NCT03416751, a Phase 1 study, has completed, sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
There is an epidemic of alcohol use disorder in the US. Alcoholism is an epidemic that spans all ages and socio-economic strata, which has a major impact on healthcare expenditure. Alcohol-associated liver disease can take the form of mild fatty liver, chronic liver disease including cirrhosis and a very acute active form known as alcoholic hepatitis. However, most patients with alcohol abuse issues with cirrhosis do not develop alcoholic hepatitis and are not willing to quit drinking. These patients are neither liver transplant candidates due to their drinking nor have any recourse to therapies directed towards the liver as is the case with alcoholic hepatitis. This is very large proportion of cirrhotic patients who do not have many therapeutic options. Prior studies have demonstrated that these patients have an altered gut-liver axis which is exacerbated by dysbiosis and a higher production of potentially toxic secondary bile acids. These secondary bile acids in turn have the potential to worsen the already impaired gut barrier in these patients, creating a vicious cycle of inflammation and further liver injury that is led by the altered microbial composition. A gut-based strategy that has the capability of "resetting" this dysbiosis could help in the amelioration of this inflammatory load and improve the prognosis of these patients.
Interventions
- OTHER Placebo
- BIOLOGICAL Fecal Microbial Transplant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-02-01 |
| Est. Completion | 2020-04-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03416751
The ClinicalTrials.gov registry entry for NCT03416751 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hunter Holmes Mcguire Veteran Affairs Medical Center, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03416751 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03416751 about?
NCT03416751 is a clinical study titled "Fecal Microbial Transplant for Alcohol Misuse in Cirrhosis". There is an epidemic of alcohol use disorder in the US. Alcoholism is an epidemic that spans all ages and socio-economic strata, which has a major impact on healthcare expenditure. Alcohol-associated liver disease can take the form of mild fatty liver, chronic liver disease including cirrhosis and a...
What is the current status of trial NCT03416751?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2018-02-01. Estimated completion is 2020-04-10.
What interventions are being tested in trial NCT03416751?
The interventions under investigation include: Placebo (OTHER), Fecal Microbial Transplant (BIOLOGICAL).
Who is sponsoring clinical trial NCT03416751?
This trial is sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center, which has 27 total clinical trials registered on ClinicalTrials.gov.
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