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NCT01846806 · ClinicalTrials.gov registry record · NA
The Role of Bacterial Overgrowth and Delayed Intestinal Transit in Hepatic Encephalopathy.
A NA study, sponsored by NYU Langone Health.
- Terminated
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT01846806 is a NA study that was terminated before completion, run by NYU Langone Health. The registered enrollment target is 10 participants.
The verdict
NCT01846806, a NA study, was terminated before completion, sponsored by NYU Langone Health.
- TERMINATED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study Summary
This is a prospective study designed to examine the role of bacterial overgrowth and delayed intestinal transit and the effect of Rifaximin with hepatic encephalopathy (HE). This study is divided into Phase A and Phase B. The purpose of Phase A is to test patients with cirrhosis to determine if they have bacterial overgrowth which may lead to slow intestinal transit and hepatic encephalopathy. The purpose of Phase B is to investigate whether the improvement found in patients with hepatic encephalopathy taking Rifaximin is also related to decreased bacterial overgrowth. Subjects' mental capacity will be assessed at each visit via interview, brief mental status, questionnaires and psychometric evaluation. Any subject who appears to have lost capacity to continue participation, as evidenced by HE grade 2 or higher, a lack of attentiveness, concentration, or understanding of evaluation, will be discontinued from the study. Female subjects of childbearing potential will be asked to comply with the use of contraception during the Phase B study period as well as throughout the time they remain on study drug.
Interventions
- OTHER Rifaximin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2012-09 |
| Est. Completion | 2016-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01846806
The ClinicalTrials.gov registry entry for NCT01846806 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Rifaximin is the first listed.
NCT01846806 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01846806 about?
NCT01846806 is a clinical study titled "The Role of Bacterial Overgrowth and Delayed Intestinal Transit in Hepatic Encephalopathy.". This is a prospective study designed to examine the role of bacterial overgrowth and delayed intestinal transit and the effect of Rifaximin with hepatic encephalopathy (HE). This study is divided into Phase A and Phase B. The purpose of Phase A is to test patients with cirrhosis to determine if they...
What is the current status of trial NCT01846806?
This trial is currently terminated. It is a NA study. The enrollment target is 10 participants. The study started on 2012-09. Estimated completion is 2016-03.
What interventions are being tested in trial NCT01846806?
The interventions under investigation include: Rifaximin (OTHER).
Who is sponsoring clinical trial NCT01846806?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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