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
|Condition or disease||Intervention/treatment||Phase|
|Cirrhosis||Drug: Rifaximin||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
400 mg bid,orally
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
- number of death [ Time Frame: 6 months ]
- numbers of liver transplantation [ Time Frame: 6 months ]
- numbers of hepatic encephalopathy [ Time Frame: 6 months ]
- Numbers of other complications of cirrhosis [ Time Frame: 6 months ]
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
|Contact: Wei-Fen Xie, MDfirstname.lastname@example.org|
|Shanghai changzheng Hospital||Recruiting|
|Shanghai, Shanghai, China, 200003|
|Contact: Xin Zeng, MD,PhD 86-21-81885345 email@example.com|
|Contact: Wen-Ping Xu, MD,PhD 86-21-81885346 firstname.lastname@example.org|
|Principal Investigator:||Wei-Fen Xie, MD||Department of Gastroenterology, Changzheng Hospital, Second Military Medical University, Shanghai|