Rifaximin Predicts the Complications of Decompensated Cirrhosis
NCT ID: NCT02074280
Last Updated: 2014-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
250 participants
INTERVENTIONAL
2013-10-31
2014-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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high dose of rifaximin
rifaximin 600 mg, bid, orally, 2 weeks and conventional treatment
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.
low dose of rifaximin
rifaximin 400 mg bid,orally, 2 weeks
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.
control
conventional treatment
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Child-Pugh B or C stage
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Changzheng Hospital
OTHER
Responsible Party
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Wei-Fen Xie
Director
Principal Investigators
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Wei-Fen Xie, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Gastroenterology, Changzheng Hospital, Second Military Medical University Shanghai
Locations
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Shanghai changzheng Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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References
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Mullen KD, Sanyal AJ, Bass NM, Poordad FF, Sheikh MY, Frederick RT, Bortey E, Forbes WP. Rifaximin is safe and well tolerated for long-term maintenance of remission from overt hepatic encephalopathy. Clin Gastroenterol Hepatol. 2014 Aug;12(8):1390-7.e2. doi: 10.1016/j.cgh.2013.12.021. Epub 2013 Dec 21.
Xu D, Gao J, Gillilland M 3rd, Wu X, Song I, Kao JY, Owyang C. Rifaximin alters intestinal bacteria and prevents stress-induced gut inflammation and visceral hyperalgesia in rats. Gastroenterology. 2014 Feb;146(2):484-96.e4. doi: 10.1053/j.gastro.2013.10.026. Epub 2013 Oct 22.
Lutz P, Parcina M, Bekeredjian-Ding I, Hoerauf A, Strassburg CP, Spengler U. Spontaneous bacterial peritonitis by Pasteurella multocida under treatment with rifaximin. Infection. 2014 Feb;42(1):175-7. doi: 10.1007/s15010-013-0449-4. Epub 2013 Mar 25.
Other Identifiers
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LPDLCC-1
Identifier Type: -
Identifier Source: org_study_id