Status:
UNKNOWN
Role of Probiotics in the Prevention of Spontaneous Bacterial Peritonitis in Cirrhotic Patients: A Randomized Placebo Control Trial
Lead Sponsor:
All India Institute of Medical Sciences
Conditions:
Spontaneous Bacterial Peritonitis
Liver Cirrhosis
Eligibility:
All Genders
13-65 years
Phase:
PHASE2
PHASE3
Brief Summary
Cirrhotic patients are predisposed to bacterial infection. A large proportion of which is spontaneous bacterial peritonitis(SBP), which are mainly caused by enteric bacteria.SBP in a cirrhotic patient...
Detailed Description
AIMS : To study the effect of a Probiotics administration in reducing the incidence of first episode of SBP among cirrhotics who have low protein(\<1 gm/dl) ascites. To study the effect of a Probiot...
Eligibility Criteria
Inclusion
- All patients with liver cirrhosis with ascites having either history of prior SBP or ascitic fluid protein \<1 gm/dl will be included in the study irrespective of etiology.
Exclusion
- Patients chronically treated with antibiotics(that disturb/alter normal gut flora) or lactulose during past 30 days.
- Patients having risk factor of small intestinal bacterial overgrowth other than cirrhosis - diabetes mellitus, history of abdominal surgery, immunomodulator drugs. Alcoholic cirrhotics who continue to take alcohol.
- Patients with active or recent G.I. bleed (within prior 7 days).
- Patients with advanced HCC, renal failure and portal vein thrombosis.
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00678613
Start Date
July 1 2007
Last Update
May 15 2008
Active Locations (1)
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1
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India, 110029