Status:
COMPLETED
Evaluation of Safety & Efficacy of Synbiotic on the Incidence and Recurrence of Spontaneous Bacterial Peritonitis (SBP) in Cirrhotics
Lead Sponsor:
Govind Ballabh Pant Hospital
Collaborating Sponsors:
Jhaver Research Foundation Limited
Conditions:
Cirrhosis With Ascites
Eligibility:
All Genders
12-75 years
Phase:
PHASE3
Brief Summary
Background: Spontaneous bacterial peritonitis (SBP) is a serious complication in patients of cirrhosis with ascites and may occur despite antibiotic prophylaxis. Small bowel dysmotility and bacterial ...
Eligibility Criteria
Inclusion
- Cirrhosis with ascites with any one of following:
- History of at least one episode of SBP, or
- Ascitic fluid protein less than or equal to 1g/dL, or
- Serum bilirubin more than or equal to 2.5 mg/dL
Exclusion
- Renal failure
- HCC
- Hepatic encephalopathy
- No consent
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00947336
Start Date
April 1 2005
End Date
April 1 2008
Last Update
July 28 2009
Active Locations (1)
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1
Department of Gastroenterology, G B Pant Hospital
New Delhi, National Capital Territory of Delhi, India, 110002