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Completed

NCT Number: NCT05545670

Allopurinol to Prevent Cirrhosis Related Morbidities

The study aims to compare the potential benefit of allopurinol in reducing the risk of developing cirrhosis-related complications, delaying the onset of hepatocellular carcinoma, and improving survival. Furthermore, the study aims to evaluate their impact on parents' related quality of life

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Key information

Conditions

Cirrhosis Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Faculty of Pharmacy

Tanta, 31679, Egypt

About this study

Cirrhosis is the late stage of liver damage and possess two phases: a compensated phase with favorable prognosis and a decompensated phase with high mortality rate.The shift from compensated to decompensated cirrhosis is characterized by the onset of complications, including ascites, hepatic encephalopathy (HE), variceal bleeding, and spontaneous bacterial peritonitis (SBP) which are associated with substantial morbidity and negative Impact on quality of life (QOL).

The gut microbiota plays an important role in cirrhosis and development of cirrhosis-related complications.

Indeed, translocation of endotoxins is increased in patients with cirrhosis and patients with more severe cirrhosis (i.e. Patients with decompensated cirrhosis, hospitalized patients) had significantly greater serum endotoxin concentrations that mediate complications of cirrhosis.

Intestinal permeability plays a role in the development of bacterial translocation and may be involved in the development of complications of cirrhosis. This 'leaky gut' phenomenon increases with the degree of liver failure and is particularly prominent in patients with cirrhosis who have experienced severe septic complications and has been implicated in the hepatic production of endotoxin-associated proinflammatory cytokines.

Intestinal mucosa alterations at the subcellular level have been reported in experimental cirrhosis, in relation to an increased oxidative stress due to overactivity in the enzyme xanthine oxidase.

Allopurinol, a competitive xanthine oxidase inhibitor, reduces oxidative stress and attenuates bacterial translocation in portal hypertensive animals, suggesting that the damaging effects of oxygen-derived free radicals and peroxidation on mucosal cells may be counteracted by a free radical scavenger.

In 2007, a pilot study demonstrated that allopurinol in patients with cirrhosis is associated with a significant reduction in oxidative stress but no effect on intestinal permeability and inflammatory markers. The study duration was only 10 days and therefore another study with a long period of time is essential.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ge 18 to 75 years old Both sex Adults with cirrhosis in a stable conditions

Exclusion criteria

  • Active SBP Renal insufficiency (serum creatinine > 2.0 mg/dl) Active GIT hemorrhage

Treatment and study plan

Placebo

Drug

not containing drugs

Allopurinol 300 MG

Drug

a competitive xanthine oxidase inhibitor, reduces oxidative stress and attenuates bacterial translocation

Primary outcomes

  1. morbidities

    Time frame: 6 moths

    occurrence or exacerbation of complication

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Allopurinol Impact on Cirrhosis Related Complications

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 19, 2022
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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