4beta-hydroxycholesterol in Cirrhosis

May 8, 2023 updated by: Janne Hukkanen, University of Oulu

4beta-hydroksikolesteroli Maksakirroosissa

The aim is to evaluate the levels of oxysterols and especially 4beta-hydroxycholesterol in patients with liver cirrhosis. Three cirrhosis cohorts are recruited: patients treated with spironolactone, patients treated with rifaximin, patients without spironolactone or rifaximin. Also three other control cohorts are recruited: patients with pneumonia, patients with Crohn's disease, patients with ulcerative colitis. The effect of the cirrhosis and its medications spironolactone and rifaximin are compared to control groups.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Oulu, Finland, 90029 OYS
        • Oulu University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with cirrhosis, pneumonia, Crohn's disease or colitis ulcerosa treated in the ward 42 of the Oulu University Hospital

Description

Inclusion Criteria:

  • Patients with cirrhosis, pneumonia, Crohn's disease or colitis ulcerosa
  • Treated in the ward 42 of the Oulu University Hospital

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ulcerative colitis
Other: There is no intervention, only research blood samples are collected
Research blood samples collected
Crohn's disease
Other: There is no intervention, only research blood samples are collected
Research blood samples collected
Liver cirrhosis with spironolactone
Other: There is no intervention, only research blood samples are collected
Research blood samples collected
Liver cirrhosis with rifaximin
Other: There is no intervention, only research blood samples are collected
Research blood samples collected
Liver cirrhosis without spironolactone or rifaximin
Other: There is no intervention, only research blood samples are collected
Research blood samples collected
Pneumonia
Other: There is no intervention, only research blood samples are collected
Research blood samples collected

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood 4beta-hydroxycholesterol concentration
Time Frame: At the time point of the blood collection - cross-sectional. One day.
Blood 4beta-hydroxycholesterol concentration
At the time point of the blood collection - cross-sectional. One day.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oulu

Investigators

  • Principal Investigator: Janne Hukkanen, MD, Oulu University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

December 11, 2019

First Submitted That Met QC Criteria

December 13, 2019

First Posted (Actual)

December 16, 2019

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4bHC kirroosissa

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cirrhosis, Liver

Clinical Trials on There is no intervention, only research blood samples are collected

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe