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NCT02400216 · ClinicalTrials.gov registry record
Deciphering the Mechanisms Involved in Microbial Translocation Across the Spectrum of HCV Associated Liver Fibrosis
A clinical trial of Cirrhosis, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- 30
- Enrollment target
- 1
- Study location
NCT02400216: Completed study of Cirrhosis, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT02400216 is a study of Cirrhosis that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 30 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
NCT02400216, a study of Cirrhosis, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- Hepatitis C infection (HCV) is a leading cause of liver disease. Normal bacteria from the intestines may spread to the liver and blood during liver disease. This is called bacterial translocation (BT). Researchers think BT may cause liver disease to worsen. Objectives: \- To study the mechanisms involved in BT in early and advanced liver disease. To find out whether BT causes liver disease to worsen. Eligibility: \- People over age 18 with HCV and clinically stable liver disease. Design: * Participants will be screened with medical history and physical exam. They will have blood tests and imaging studies. * Participants will have 2 outpatient visits and a 3-day stay at the clinic. * At visit 1, participants will have urine and blood tests. They will have a magnetic resonance imaging (MRI) scan. A solution will be injected into a vein. The MRI scanner is a metal cylinder surrounded by a magnetic field. The participant will lie on a table that slides in and out of the cylinder. * At visit 2, a substance will be injected into a vein and swallowed. Participants will then have blood drawn 5 times over 90 minutes. * During the inpatient stay, serial blood tests will be drawn. * Participants will give 2 stool samples and have another MRI. * A needle will be inserted through the chest wall into a vein inside the liver, guided by ultrasound. The blood pressure inside this vein will be measured and blood will be drawn from it. About 1 inch of liver tissue will be removed. * A study investigator will call participants to discuss all test results.
Primary Outcome
Assess the extent of BT, explore possible mechanisms accounting for its occurrence and evaluate its effects on the immune system in different stages of liver fibrosis
Conditions Studied
Interventions
- DRUG dual cholate
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2015-05-29 |
| Est. Completion | 2017-04-25 |
What the finished NCT02400216 record still lists
NCT02400216 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 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 1 condition, with Cirrhosis appearing as the primary indexed condition, and to 1 intervention - of which dual cholate is the first listed.
NCT02400216 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02400216 about?
NCT02400216 is a clinical study titled "Deciphering the Mechanisms Involved in Microbial Translocation Across the Spectrum of HCV Associated Liver Fibrosis". Background: \- Hepatitis C infection (HCV) is a leading cause of liver disease. Normal bacteria from the intestines may spread to the liver and blood during liver disease. This is called bacterial translocation (BT). Researchers think BT may cause liver disease to worsen. Objectives: \- To study ...
What is the current status of trial NCT02400216?
This trial is currently completed. The enrollment target is 30 participants. The study started on 2015-05-29. Estimated completion is 2017-04-25.
What conditions does trial NCT02400216 study?
This clinical trial studies the following conditions: Cirrhosis.
What interventions are being tested in trial NCT02400216?
The interventions under investigation include: dual cholate (DRUG).
Who is sponsoring clinical trial NCT02400216?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02400216 being conducted?
This trial has 1 study location across Maryland. 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 NCT02400216's enrollment target sits among peer trials
30 31st of 53 higher than 13 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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