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Trial record 46 of 257 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND broad

Rifaximin Reduces the Complications of Decompensated Cirrhosis: a Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT02190357
Recruitment Status : Unknown
Verified September 2016 by Wei-Fen Xie, Shanghai Changzheng Hospital.
Recruitment status was:  Recruiting
First Posted : July 15, 2014
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):
Wei-Fen Xie, Shanghai Changzheng Hospital

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 endotoxemia. Rifaximin is an antibiotic that is virtually non-absorbed after oral administration and exhibits broad spectrum antimicrobial activity against both aerobic and anaerobic gram-positive and gram-negative microorganisms within the gastrointestinal tract. It has been suggested that oral prophylactic antibiotics or bowel decontamination might improve long-term outcomes in patients with cirrhosis. The aim of this study was to explore the effect of rifaximin on the complications of advanced cirrhosis.

Condition or disease Intervention/treatment Phase
Cirrhosis Drug: Rifaximin Phase 4

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 endotoxemia. Cirrhotics with bacterial translocation and endotoxemia manifest hemodynamic derangement with lower systemic vascular resistance, higher cardiac output, and lower mean arterial pressure. Moreover, endotoxins may increase portal pressure by increasing vascular resistance which may be promoted through the cytokine-stimulated intrahepatic release of endothelin and cyclo-oxygenase products.

Indeed, bacterial infections are common in cirrhotic patients and have approximately 30% mortality at one month and a further 30% mortality at 12 months as documented in a systematic review comprising almost 12 000 patients. It follows that altering gut flora to decrease endotoxin levels may lead to improved prognosis in cirrhosis. Rifaximin is an antibiotic that is virtually non-absorbed after oral administration and exhibits broad spectrum antimicrobial activity against both aerobic and anaerobic gram-positive and gram-negative microorganisms within the gastrointestinal tract. It has been suggested that oral prophylactic antibiotics or bowel decontamination might improve long-term outcomes in patients with cirrhosis, not only by reducing the risk of infections but also by reducing hepatic vein pressure gradient (HVPG).

The aim of this study was to explore the effect of rifaximin on the complications of advanced cirrhosis.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rifaximin Reduces the Complications of Decompensated Cirrhosis
Study Start Date : August 2014
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis
Drug Information available for: Rifaximin

Arm Intervention/treatment
Experimental: rifaximin
400 mg bid,orally
Drug: Rifaximin
Rifaximin is an antibiotic that is virtually non-absorbed after oral administration and exhibits broad spectrum antimicrobial activity against both aerobic and anaerobic gram-positive and gram-negative microorganisms within the gastrointestinal tract.

No Intervention: controlled group
no intervention



Primary Outcome Measures :
  1. number of death [ Time Frame: 6 months ]
  2. numbers of liver transplantation [ Time Frame: 6 months ]
  3. numbers of hepatic encephalopathy [ Time Frame: 6 months ]
  4. Numbers of other complications of cirrhosis [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  1. 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
  2. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02190357


Contacts
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Contact: Wei-Fen Xie, MD 86-21-81885341 coss2008@yeah.net

Locations
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China, Shanghai
Shanghai changzheng Hospital Recruiting
Shanghai, Shanghai, China, 200003
Contact: Xin Zeng, MD,PhD    86-21-81885345    zengxinmd1978@163.com   
Contact: Wen-Ping Xu, MD,PhD    86-21-81885346    xwp198527@sina.com   
Sponsors and Collaborators
Shanghai Changzheng Hospital
Investigators
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Principal Investigator: Wei-Fen Xie, MD Department of Gastroenterology, Changzheng Hospital, Second Military Medical University, Shanghai

Publications of Results:
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Responsible Party: Wei-Fen Xie, Director, Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier: NCT02190357     History of Changes
Other Study ID Numbers: LPDLCC-2
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016
Keywords provided by Wei-Fen Xie, Shanghai Changzheng Hospital:
Cirrhosis
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Rifaximin
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents