Effect of Administration of Rifaximin on the Portal Pressure of Patients With Liver Cirrhosis and Esophageal Varices

NCT ID: NCT02508623

Last Updated: 2015-07-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2017-07-31

Brief Summary

The purpose of this study is to assess whether the add of Rifaximin in patients with liver cirrhosis and esophageal varices treated with a standard therapy with beta blockers, leads to a significant reduction of portal hypertension.

Detailed Description

It is well recognized that the gut flora may play an important role in the development of complications of liver cirrhosis, such as hepatic encephalopathy (HE), spontaneous bacterial peritonitis (SBP) and variceal bleeding, which are are directly caused or aggravated by the translocation of enteric bacteria or their products into the blood of cirrhotic patients.Preliminary studies have shown that selective intestinal decontamination appears to ameliorate the hyperdynamic circulatory state of cirrhosis. The investigators hypothesize that a modulation of gut microbiota by administering a non-adsorbable antibiotic, in addition to beta-blockers, can be a safe strategy to reduce the portal pressure, influencing favorably hemodynamics of portal circulation. Thus, the purpose of this study is to evaluate if in patients with liver cirrhosis and esophageal varices at high risk of bleeding, Rifaximin, administered in addition to standard therapy with beta - blockers (propranolol), for a time of 60 days: leads to a significant reduction of Hepatic Venous Pressure Gradient (it will be assessed by hepatic vein catheterization), 2) modify the intestinal flora in favor of specific families of bacteria (it will be assessed by fecal microbiota analysis), 3) change systemic inflammatory responses (it will be assessed by serum pro-inflammatory cytokines) 4) change in cognitive functions (it will be assessed by neuropsychological and electroencephalogram evaluations).

Conditions

Liver Cirrhosis; Portal Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Rifaximin

Rifaximin 550 mg 1 tablet BID for 60 days

Group Type: EXPERIMENTAL

Rifaximin

Intervention Type: DRUG

Rifaximin 550 mg tablet BID for 60 days

Placebo

Placebo 1 tablet BID for +60 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo 1 tablet BID for 60 days

Interventions

Rifaximin

Rifaximin 550 mg tablet BID for 60 days

Intervention Type: DRUG

Placebo

Placebo 1 tablet BID for 60 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosis of liver cirrhosis (based on clinical, biochemical and radiological criteria with or without liver biopsy)
• Presence of esophageal varices at high risk of bleeding
• Hepatic Venous Pressure Gradient > 12 mmHg.
• 19≤ age ≤75
• Informed Consent

Exclusion Criteria

• Patients already treated with beta blockers
• Treatment with systemic antibiotics and/or non-absorbable intestinal antibiotics in the previous two weeks
• Bacterial infection, spontaneous bacterial peritonitis
• overt hepatic encephalopathy in the last week
• active gastrointestinal bleeding, or in the last week
• active alcoholism or drug abuse in last 3 weeks
• Acute Alcoholic Hepatitis
• Hepatocellular carcinoma or other neoplasm
• significant coronary artery disease (angina NYHA III/IV), congestive heart failure (NYHA III/IV), relevant cardiomyopathy, history of myocardial infarct within the last 12 months
• Contraindications to the administration of beta blockers; allergy to Rifaximin
• Pregnancy or breastfeeding
• Refusal to participate

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Padova

OTHER

Sponsor Role: lead

Responsible Party

Piero Amodio

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Piero Amodio

Role: PRINCIPAL_INVESTIGATOR

University of Padova

Locations

Azienda Ospedaliera di Padova

Padua, Italy, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Francesca Campagna, MD

Role: CONTACT

francescacampagna3@gmail.com

+39 0498218675

Facility Contacts

Claudio Dario

Role: primary

+39 0498212105

Other Identifiers

2014-000102-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

3250/AO/14

Identifier Type: -

Identifier Source: org_study_id