Evaluation of Safety & Efficacy of Synbiotic on the Incidence and Recurrence of Spontaneous Bacterial Peritonitis (SBP) in Cirrhotics
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.
|Cirrhosis With Ascites||Drug: Norfloxacin + Synbiotic Drug: Norfloxacin + Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
|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|
- Development of SBP [ Time Frame: 6 months ]
- Mortality [ Time Frame: 6 months ]
|Study Start Date:||April 2005|
|Study Completion Date:||April 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
|Active Comparator: Norfloxacin + Synbiotic||
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.
|Placebo Comparator: Norfloxacin + Placebo||
Drug: Norfloxacin + Placebo
Norfloxacin 400 mg once daily with placebo
Please refer to this study by its ClinicalTrials.gov identifier: NCT00947336
|Department of Gastroenterology, G B Pant Hospital|
|New Delhi, Delhi, India, 110002|