Intestinal Barrier Function and Liver Cirrhosis

• Conditions: Liver Cirrhosis

• Registration Number: NCT01081236
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2010-03-04
• Study First Submitted QC: 2010-03-04
• Study First Posted: 2010-03-05
• Study Start: 2010-05
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-15
• Last Update Posted: 2010-12-16
• Primary Completion: 2012-05
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 62

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary aim is to study differences in small and large intestinal permeability between patients with compensated and decompensated cirrhosis by means of a sugar permeability test	2 years

Secondary Outcome Measures

Name	Time	Method
To assess tight junction structure and proteins in biopsy specimens of small and large intestine	2 years

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands