Intestinal Barrier Function and Liver Cirrhosis
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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.
Condition |
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Liver Cirrhosis |
Study Type: | Observational |
Study Design: | Observational Model: Cohort Time Perspective: Prospective |
Official Title: | The Role of the Intestinal Barrier Function in Liver Cirrhosis |
- 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 ] [ Designated as safety issue: No ]
- To assess tight junction structure and proteins in biopsy specimens of small and large intestine [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Estimated Enrollment: | 62 |
Study Start Date: | May 2010 |
Estimated Study Completion Date: | May 2012 |
Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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Compensated liver cirrhosis |
Decompensated liver cirrhosis |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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)
Contact: Kirsten Pijls, MD | +31433882157 | k.pijls@intmed.unimaas.nl |
Netherlands | |
Maastricht University Medical Center | Recruiting |
Maastricht, Limburg, Netherlands | |
Contact: Kirsten Pijls, MD 0031433882157 k.pijls@maastrichtuniversity.nl | |
Principal Investigator: Ad Masclee, MD PhD | |
Sub-Investigator: Kirsten Pijls, MD |
Principal Investigator: | A Masclee, MD, PhD | Maastricht University Medical Center |
No publications provided
Responsible Party: | Prof. dr. A. Masclee, Maastricht University Medical Center, Division of Gastroenterology-Hepatology |
ClinicalTrials.gov Identifier: | NCT01081236 History of Changes |
Other Study ID Numbers: | MEC 09-2-125 |
Study First Received: | March 4, 2010 |
Last Updated: | December 15, 2010 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Maastricht University Medical Center:
liver cirrhosis intestinal permeability microbiota complications |
Additional relevant MeSH terms:
Liver Cirrhosis Fibrosis Liver Diseases Digestive System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on October 17, 2012