The Role of the Intestinal Barrier Function in Liver Cirrhosis

Recruiting

• Conditions: 10019654; liver disease; liver cirrhosis

• Registration Number: NL-OMON36372
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 93

Inclusion Criteria

Patients with liver cirrhosis:

- 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 75 years;Healthy individuals:

- Normal medical history and physical examination
- Age between 18 and 75 years
- BMI between 18-30 kg/m-2

Exclusion Criteria

Patients with liver cirrhosis:

- Known gastrointestinal diseases (such as inflammatory bowel disease and celiac disease),
chronic renal disease (i.e. a glomular filtration rate of <= 60 ml/min per 1.73 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);Healthy individuals:

- Abnormal liver tests (i.e. ALT, AST, γ-GT) according to the reference values for normal ranges of the liver enzymes at the laboratory of clinical chemistry of the Maastricht University medical Center.
- History of gastrointestinal diseases and/or liver diseases.
- Major abdominal surgery interfering with gastrointestinal function (except for uncomplicated appendectomy, cholecystectomy and hysterectomy, other surgery upon judgement of the principle investigator)
- History of alcohol abuse or current excessive alcohol consumption (> 2 alcoholic beverages per day or > 14 alcoholic beverages per week)
- Use of medication (that may interact with intestinal permeability i.e. NSAIDs, proton pump inhibitors)
- Administration of investigational drugs in the 180 days prior to the study

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary aim is to study differences in small and large intestinal<br /><br>permeability between patients with compensated and decompensated cirrhosis by<br /><br>means of a sugar permeability test.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess tight junction structure and proteins in biopsy specimens of small<br /><br>and large intestine.<br /><br><br /><br>To assess intestinal microbiota in fecal samples and in biopsy specimens of<br /><br>both small and large intestine using molecular methods.<br /><br><br /><br>To assess inflammatory, oxidative stress markers, and cytokine profile<br /><br><br /><br>To assess VOC by analyzing human breath samples.<br /><br><br /><br>To study components which may affect the intestinal integrity by using a<br /><br>3-dimensional Caco-2 cell culture model.<br /><br><br /><br>To compare the results of the above mentioned tests between patients with<br /><br>compensated and decompensated cirrhosis.<br /><br><br /><br>To compare the decompensated situation with the stable situation in the same<br /><br>patients after three to six months.<br /><br><br /><br>To compare cirrhotic patients with healthy controls.</p><br>