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

NCT00947336 | Completed Phase 3

• 1 other identifier: 2009-PHT-01
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis With Ascites

Outcome Measures

Primary Outcomes (1)

• Development of SBP

  6 months

Secondary Outcomes (1)

• Mortality

  6 months

Study Arms (2)

Norfloxacin + Synbiotic

ACTIVE COMPARATOR

Drug: Norfloxacin + Synbiotic

Norfloxacin + Placebo

PLACEBO COMPARATOR

Drug: Norfloxacin + Placebo

Interventions

Norfloxacin + Synbiotic DRUG

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.

Norfloxacin + Synbiotic

Norfloxacin + Placebo DRUG

Norfloxacin 400 mg once daily with placebo

Norfloxacin + Placebo

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Renal failure
• HCC
• Hepatic encephalopathy
• No consent

Sponsors & Collaborators

• Govind Ballabh Pant Hospital: lead
• Jhaver Research Foundation Limited: collaborator

Study Sites (1)

Department of Gastroenterology, G B Pant Hospital

New Delhi, National Capital Territory of Delhi, 110002, India

Location

MeSH Terms

Interventions

Norfloxacin; Synbiotics

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Prebiotics; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Probiotics; Food and Beverages

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 27, 2009
• First Posted: July 28, 2009
• Study Start: April 1, 2005
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: July 28, 2009

Record last verified: 2009-07

Locations

IN (1)