Intestinal Barrier Function and Liver Cirrhosis

The Role of the Intestinal Barrier Function in Liver Cirrhosis

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01081236

Enrollment

Registered

2010-03-05

Start date

2010-05-31

Completion date

2012-05-31

Last updated

2010-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis

Keywords

liver cirrhosis, intestinal permeability, microbiota, complications

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Netherlands

Contacts

Primary ContactKirsten Pijls, MD

k.pijls@intmed.unimaas.nl+31433882157

Outcome results