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

Phase 3

Completed

• Conditions: Cirrhosis With Ascites
• Interventions: Drug: Norfloxacin + Synbiotic; Drug: Norfloxacin + Placebo

• Registration Number: NCT00947336
• Lead Sponsor: Govind Ballabh Pant Hospital

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2009-07
• Study First Submitted: 2009-07-27
• Study First Submitted QC: 2009-07-27
• Last Update Submitted: 2009-07-27
• Study First Posted: 2009-07-28
• Last Update Posted: 2009-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• 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 Criteria

• Renal failure
• HCC
• Hepatic encephalopathy
• No consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Norfloxacin + Synbiotic	Norfloxacin + Synbiotic	-
Norfloxacin + Placebo	Norfloxacin + Placebo	-

Primary Outcome Measures

Name	Time	Method
Development of SBP	6 months

Secondary Outcome Measures

Name	Time	Method
Mortality	6 months

Trial Locations

Locations (1)

Department of Gastroenterology, G B Pant Hospital; 🇮🇳 New Delhi, Delhi, India