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Deciphering the Mechanisms Involved in Microbial Translocation Across the Spectrum of HCV Associated Liver Fibrosis

NCT02400216 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-04-29

No results posted yet for this 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.

Conditions

  • Cirrhosis

Interventions

DRUG

dual cholate

test for defining disease severity

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Theo Heller, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-29
Primary Completion
2017-02-24
Completion
2017-04-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02400216 on ClinicalTrials.gov