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Trial record 47 of 259 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND broad

Rifaximin Predicts the Complications of Decompensated Cirrhosis

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ClinicalTrials.gov Identifier: NCT02074280
Recruitment Status : Unknown
Verified February 2014 by Wei-Fen Xie, Shanghai Changzheng Hospital.
Recruitment status was:  Recruiting
First Posted : February 28, 2014
Last Update Posted : February 28, 2014
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 suitable dose of rifaximin to alleviate endotoxemia and prevent 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 suitable dose of rifaximin to alleviate endotoxemia and prevent the complications of advanced cirrhosis.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Rifaximin Predicts the Complications of Decompensated Cirrhosis: a Randomized Controlled Trial
Study Start Date : October 2013
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis
Drug Information available for: Rifaximin

Arm Intervention/treatment
Experimental: high dose of rifaximin
rifaximin 600 mg, bid, orally, 2 weeks and conventional treatment
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.

Experimental: low dose of rifaximin
rifaximin 400 mg bid,orally, 2 weeks
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: control
conventional treatment



Primary Outcome Measures :
  1. Serum endotoxin level [ Time Frame: 4 weeks ]
  2. Hydrogen breath test [ Time Frame: 4 weeks ]
  3. Fecal flora [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Liver biochemistry tests [ Time Frame: 4 weeks ]
  2. Numbers of complications of cirrhosis [ Time Frame: 4 weeks ]
  3. Serum levels of inflammatory factors [ Time Frame: 4 weeks ]


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

Inclusion Criteria:

  • Decompensated cirrhosis
  • Child-Pugh B or C stage

Exclusion Criteria:

  • severe complications of cirrhosis in the past one month.
  • renal dysfunction.
  • administration of antibiotics in the past two weeks.
  • malignant tumors.
  • HIV infection.
  • severe heart and lung disease
  • sensitivity to rifaximin
  • Pregnancy and lactation woman
  • Patients who have took part in other clinical trials in the past three months.

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): NCT02074280


Contacts
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Contact: Wei-Fen Xie, MD 86-21-81885346 coss2008@yeah.net

Locations
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China, Shanghai
Shanghai changzheng Hospital Recruiting
Shanghai, Shanghai, China, 200003
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:
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Responsible Party: Wei-Fen Xie, Director, Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier: NCT02074280     History of Changes
Other Study ID Numbers: LPDLCC-1
First Posted: February 28, 2014    Key Record Dates
Last Update Posted: February 28, 2014
Last Verified: February 2014
Keywords provided by Wei-Fen Xie, Shanghai Changzheng Hospital:
rifaximin
endotoxemia
cirrhosis
advanced 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