Probiotics for the Prevention of Major Complications of Cirrhosis
1 other identifier
interventional
50
1 country
1
Brief Summary
The purpose of this study is to determine whether probiotics are effective in the prevention of the complications of liver cirrhosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2005
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 9, 2006
CompletedFirst Posted
Study publicly available on registry
April 11, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedMay 22, 2008
April 1, 2007
April 9, 2006
May 21, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The effect of probiotics on the rate of complications of liver cirrhosis (variceal bleeding, hepatic encephalopathy, SBP)
Secondary Outcomes (3)
Hospital Admissions due to complications of cirrhosis
Ammonia blood levels
Hepatic and renal function
Interventions
Eligibility Criteria
You may qualify if:
- Patients with liver cirrhosis with at least one of the followings
- )Major complication of cirrhosis in the past (including variceal bleeding, encephalopathy and SBP) 2)Evidence for portal hypertension 3)Reduced hepatic synthetic function
You may not qualify if:
- Patients with alcoholic cirrhosis who still consume alcohol
- Patients that are chronically treated with antibiotics or lactulose -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Meir Medical Centerlead
- Ambrosia - SupHerb Ltd.collaborator
Study Sites (1)
Meir Medical Center
Kfar Saba, Israel
Related Publications (4)
Liu Q, Duan ZP, Ha DK, Bengmark S, Kurtovic J, Riordan SM. Synbiotic modulation of gut flora: effect on minimal hepatic encephalopathy in patients with cirrhosis. Hepatology. 2004 May;39(5):1441-9. doi: 10.1002/hep.20194.
PMID: 15122774BACKGROUNDPereg D, Kimhi O, Tirosh A, Orr N, Kayouf R, Lishner M. The effect of fermented yogurt on the prevention of diarrhea in a healthy adult population. Am J Infect Control. 2005 Mar;33(2):122-5. doi: 10.1016/j.ajic.2004.11.001.
PMID: 15761413BACKGROUNDSzajewska H, Kotowska M, Mrukowicz JZ, Armanska M, Mikolajczyk W. Efficacy of Lactobacillus GG in prevention of nosocomial diarrhea in infants. J Pediatr. 2001 Mar;138(3):361-5. doi: 10.1067/mpd.2001.111321.
PMID: 11241043BACKGROUNDPochapin M. The effect of probiotics on Clostridium difficile diarrhea. Am J Gastroenterol. 2000 Jan;95(1 Suppl):S11-3. doi: 10.1016/s0002-9270(99)00809-6.
PMID: 10634221BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Pereg, MD
Meir Medical Center, Kfar-Sava, Israel
- PRINCIPAL INVESTIGATOR
Yona Kitay-Cohen, MD
Meir Medical Center, Kfar-Sava, Israel
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 9, 2006
First Posted
April 11, 2006
Study Start
April 1, 2005
Study Completion
October 1, 2007
Last Updated
May 22, 2008
Record last verified: 2007-04