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

Cirrhosis With Ascites Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00947336
• Other study ID #: 2009-PHT-01
• Status: Completed
• Phase: Phase 3
• First received: July 27, 2009
• Last updated: July 27, 2009
• Start date: April 2005
• Est. completion date: April 2008

Study information

• Verified date: July 2009
• Source: Govind Ballabh Pant Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cirrhosis With Ascites
• Peritonitis

Intervention

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.
• Norfloxacin + Placebo
Norfloxacin 400 mg once daily with placebo

Locations

Country	Name	City	State
India	Department of Gastroenterology, G B Pant Hospital	New Delhi	Delhi

Sponsors (2)

Lead Sponsor	Collaborator
Govind Ballabh Pant Hospital	Jhaver Research Foundation Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of SBP		6 months	No
Secondary	Mortality		6 months	Yes