NCT00947336

Evaluation of Safety & Efficacy of Synbiotic on the Incidence and Recurrence of Spontaneous Bacterial Peritonitis (SBP) in Cirrhotics

Evaluation of Safety and Efficacy of Synbiotic on the Incidence and Recurrence of Spontaneous Bacterial Peritonitis in Cirrhotics: A Randomized, Double Blind Placebo Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Govind Ballabh Pant Hospital · Other Government
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

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 overgrowth have been documented to be related to SBP. Aims: To investigate whether addition of prebiotic plus probiotics (synbiotics) to norfloxacin enhances the efficacy of norfloxacin in prevention of SBP in high risk patients with ascites. Methods: A prospective, double blind, randomized controlled trial was conducted in consecutive high-risk cirrhotic patients with ascites who had either recovered from an episode of SBP (secondary prophylaxis) or who never had SBP but were at high risk for development of SBP (low ascitic fluid protein or serum bilirubin ≥2.5 mg/dL; primary prophylaxis). Norfloxacin 400 mg once daily with synbiotic capsules (Streptococcus faecalis JPC 30 million, Clostridium butyricum 2 million, Bacillus mesentericus JPC 1 million, Lactobacillus sporogenes 50 million spores) 2 t.i.d. (group I) or norfloxacin 400 mg once daily with placebo (group II) was given and occurrence of SBP within a period of 6 months (primary endpoint) or side-effects of therapy and mortality (secondary endpoints) were recorded. Every patient received IV albumin to maintain a serum albumin level of \>3.2 g/dl. SBP was treated with intravenous antibiotics with albumin.

Conditions

• Cirrhosis With Ascites

Interventions

Type	Name	Description
DRUG	Norfloxacin + Synbiotic	Norfloxacin 400 mg once daily with synbiotic capsules (Streptococcus faecalis JPC 30 million, Clostridium butyricum 2 million, Bacillus mesentericus JPC 1 million, Lactobacillus sporogenes 50 million spores) 2 t.i.d.
DRUG	Norfloxacin + Placebo	Norfloxacin 400 mg once daily with placebo

Timeline

• Start date: 2005-04-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2009-07-28
• Last updated: 2009-07-28

Locations

1 site across 1 country: India