Status:
UNKNOWN
Probiotics in the Prevention of Hepatocellular Carcinoma in Cirrhosis
Lead Sponsor:
Austral University, Argentina
Conditions:
Microbiota
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Background. The main risk factor for the development of hepatocellular carcinoma (HCC) is cirrhosis of any etiology, with an annual risk between 1 and 6%, being currently the leading cause of death in...
Detailed Description
Research question Does the modulation of gut microbiome with probiotics prevents the development of hepatocellular carcinoma in patients with cirrhosis? The aim of this study is to evaluate the effica...
Eligibility Criteria
Inclusion
- signed Informed Consent (CI), obtained before carrying out any specific procedure of the study
- Clinical or histological diagnosis of cirrhosis
- Child Pugh A or B
- Presence of clinical signs of portal hypertension: esophagogastric varices or hypertensive gastropathy or edematous ascitic syndrome or encephalopathy.
Exclusion
- History of hepatocellular carcinoma prior to randomization
- Solid organ transplant.
- Immunosuppressive treatment.
- Previous treatment (during the last 6 months prior to the inclusion of the study) or current with pre or probiotics.
- Current antibiotic treatment for any reason.
- Active alcoholism: alcohol consumption in the last 3 months prior to randomization.
- History or current history of other neoplasms.
- Major surgical intervention or serious traumatic injury in the 28 days prior to randomization.
- Unstable angina (angina symptoms at rest, recently started angina, or within the last 3 months of randomization) or myocardial infarction in the 6 months prior to randomization.
- Uncontrolled cardiac arrhythmia, valvular heart disease.
- Infection grade\> 2 in progress, according to the NCA CTCAE criteria, version 4.0.
- Inflammatory bowel disease including ulcerative colitis and Crohn's disease.
- Celiac Disease.
- Diarrhea secondary to any germ or commensal, including Clostridium difficile diarrhea within 6 months prior to randomization.
- Any malabsorption disorder.
- Chronic renal failure with hemodialysis requirement.
- Known hypersensitivity to any of the study drugs, to the study drug classes or to the excipients of its formulation.
- Pregnancy or breast feeding.
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2023
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT03853928
Start Date
May 1 2019
End Date
May 1 2023
Last Update
February 27 2019
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