Intestinal Barrier Function and Liver Cirrhosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01081236
Recruitment Status : Unknown
Verified December 2010 by Maastricht University Medical Center.
Recruitment status was:  Recruiting
First Posted : March 5, 2010
Last Update Posted : December 16, 2010
Information provided by:
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.

Condition or disease
Liver Cirrhosis

Study Type : Observational
Estimated Enrollment : 62 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of the Intestinal Barrier Function in Liver Cirrhosis
Study Start Date : May 2010
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Compensated liver cirrhosis
Decompensated liver cirrhosis

Primary Outcome Measures :
  1. 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 [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. To assess tight junction structure and proteins in biopsy specimens of small and large intestine [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will be selected from a hospital providing both secondary and tertiary care

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01081236

Contact: Kirsten Pijls, MD +31433882157

Maastricht University Medical Center Recruiting
Maastricht, Limburg, Netherlands
Contact: Kirsten Pijls, MD    0031433882157   
Principal Investigator: Ad Masclee, MD PhD         
Sub-Investigator: Kirsten Pijls, MD         
Sponsors and Collaborators
Maastricht University Medical Center
Principal Investigator: A Masclee, MD, PhD Maastricht University Medical Center

Responsible Party: Prof. dr. A. Masclee, Maastricht University Medical Center, Division of Gastroenterology-Hepatology Identifier: NCT01081236     History of Changes
Other Study ID Numbers: MEC 09-2-125
First Posted: March 5, 2010    Key Record Dates
Last Update Posted: December 16, 2010
Last Verified: December 2010

Keywords provided by Maastricht University Medical Center:
liver cirrhosis
intestinal permeability

Additional relevant MeSH terms:
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases