Status:
UNKNOWN
Rifaximin Reduces the Complications of Decompensated Cirrhosis: a Randomized Controlled Trial
Lead Sponsor:
Shanghai Changzheng Hospital
Conditions:
Cirrhosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Cirrhotic patients are predisposed to intestinal dysmotility, bacterial overgrowth, and increased intestinal permeability all leading to an increase in bacterial translocation and increased endotoxemi...
Detailed Description
Cirrhotic patients are predisposed to intestinal dysmotility, bacterial overgrowth, and increased intestinal permeability all leading to an increase in bacterial translocation and increased endotoxemi...
Eligibility Criteria
Inclusion
- Eligicility criteria (1) Willing to give written informed consent and comply with the study restrictions and requirements (2) Age from 18 to 75 years at screening (3) Clinical diagnosis of decompensated liver cirrhosis
- Exclusion criteria (1) Episodes of overt hepatic encephalopathy (HE), esophageal gastric variceal bleeding (EGVB) or spontaneous bacterial peritonitis (SBP) within one month (2) Hepatitis B Virus (HBV) DNA ≥ 500 copy/ml (3) Standard antiviral treament duration less than six months for patients receiving antiviral treatment for hepatitis B or hepatitis C (4) Planned to receive or change the antiviral treament projects at the screening (5) Unwilling to stop alcohol abuse after inclusion (≥20 g/ d for women or ≥40 g/d for men) (6) Serum total bilirubin ≥ 170 μmol/L (7) Serum sodium level \< 125 mmol/L (8) White blood cell count \< 1×109/L (9) Serum creatinine ≥ 1.2 fold of upper limits of normal (10) Clinically diagnosed or suspected as liver malignancy (11) Previous use of antibiotics within two weeks before inclusion (12) HIV seropositivity (13) Poorly controlled hypertension, diabetes mellitus or other severe heart and lung diseases (14) Known hypersensitivity to rifaximin (15) Pregnancy and lactation woman (16) Participated in other studies within three months before screening (17) Not suitble for participating the study judged by investigators
Exclusion
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2019
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT02190357
Start Date
August 1 2014
End Date
August 1 2019
Last Update
September 14 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shanghai changzheng Hospital
Shanghai, Shanghai Municipality, China, 200003