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Intestinal Barrier Function and Liver Cirrhosis

NCT ID: NCT01081236

Last Updated: 2010-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-05-31

Brief Summary

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Patients with liver cirrhosis have an increased risk to develop life-threatening complications such as spontaneous bacterial peritonitis (SBP). Impairment in the intestinal barrier, changes in numbers and composition of the intestinal microbiota and alterations in immune defenses have been suggested to be involved in liver cirrhosis and its complications. Dysfunction in the intestinal barrier for example results in the ongoing passage of toxic substances from the gastrointestinal tract that may damage the liver, leading to oxidative stress, inflammation and eventually liver cirrhosis. In addition, bacterial translocation is considered a key step in the development of spontaneous infections, mainly SBP, in patients with liver cirrhosis.

The investigators hypothesize that patients with decompensated liver cirrhosis have a more impaired intestinal epithelial barrier and altered intestinal microbiota than patients with compensated liver cirrhosis.

Detailed Description

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Conditions

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Liver Cirrhosis

Keywords

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liver cirrhosis intestinal permeability microbiota complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Compensated liver cirrhosis

No interventions assigned to this group

Decompensated liver cirrhosis

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Liver cirrhosis of any cause
* A score of greater-than or equal to 5 assessed according to the Child-Pugh classification
* Age between 18 and 65 years

Exclusion Criteria

* Known gastrointestinal diseases (such as inflammatory bowel disease and celiac disease), chronic renal disease (i.e. a glomerular filtration rate of less-than or equal to 60 ml/min per 173 m2 estimated from the Modification of Diet in Renal Disease (MDRD) equation) or Diabetes Mellitus
* Major abdominal surgery interfering with gastrointestinal function (except for uncomplicated appendectomy, cholecystectomy and hysterectomy, other surgery upon judgement of the principle investigator)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Maastricht University Medical Center, Division of Gastroenterology-Hepatology

Principal Investigators

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A Masclee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

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Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Kirsten Pijls, MD

Role: CONTACT

Phone: +31433882157

Email: [email protected]

Facility Contacts

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Kirsten Pijls, MD

Role: primary

Other Identifiers

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MEC 09-2-125

Identifier Type: -

Identifier Source: org_study_id