Intestinal Barrier Function and Liver Cirrhosis

NCT01081236 | Unknown

• 1 other identifier: MEC 09-2-125
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis

Keywords

liver cirrhosis; intestinal permeability; microbiota; complications

Outcome Measures

Primary Outcomes (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

  2 years

Secondary Outcomes (1)

• To assess tight junction structure and proteins in biopsy specimens of small and large intestine

  2 years

Study Arms (2)

Compensated liver cirrhosis

Decompensated liver cirrhosis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be selected from a hospital providing both secondary and tertiary care

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• A Masclee, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirsten Pijls, MD

CONTACT

+31433882157; k.pijls@intmed.unimaas.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: March 5, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: December 16, 2010

Record last verified: 2010-12

Locations

NL (1)