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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cirrhosis With Ascites

Intervention / Treatment
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* Drug: Norfloxacin + Synbiotic
* Drug: Norfloxacin + Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Norfloxacin + Synbiotic<br> | Drug: Norfloxacin + Synbiotic<br>* 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.<br>|
| Placebo Comparator: Norfloxacin + Placebo<br> | Drug: Norfloxacin + Placebo<br>* Norfloxacin 400 mg once daily with placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of SBP |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 6 months |