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Intestinal Barrier Function and Liver Cirrhosis

Maastricht University Medical Centre (MUMC) logo

Maastricht University Medical Centre (MUMC)

Status

Unknown

Conditions

Liver Cirrhosis

Study type

Observational

Funder types

Other

Identifiers

NCT01081236
MEC 09-2-125

Details and patient eligibility

About

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.

Enrollment

62 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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)

Trial design

62 participants in 2 patient groups

Compensated liver cirrhosis
Decompensated liver cirrhosis

Trial contacts and locations

1

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Central trial contact

Kirsten Pijls, MD

Data sourced from clinicaltrials.gov

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