NCT00947336

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

Completed Phase 3 Last updated 27 July 2009

What this trial tests

Phase 3 trial testing Norfloxacin + Synbiotic in Cirrhosis With Ascites in 110 participants. Completed in 1 April 2008.

Timeline

1 April 2005

Primary endpoint
1 April 2008

1 April 2008

Quick facts

Lead sponsor	Govind Ballabh Pant Hospital
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	double
Primary purpose	prevention
Enrollment	110
Start date	1 April 2005
Primary completion	1 April 2008
Estimated completion	1 April 2008
Sites	1 location across India

Drugs / interventions tested

• Norfloxacin + Synbiotic — full drug profile →
• Norfloxacin + Placebo — full drug profile →

Conditions studied

• Cirrhosis With Ascites — all drugs for Cirrhosis With Ascites →

Sponsor

Govind Ballabh Pant Hospital

Who can join

Adults 12 to 75, any sex, with Cirrhosis With Ascites. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Development of SBP
  Time frame: 6 months

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.