Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Jhaver Research Foundation Limited
Information provided by:
Govind Ballabh Pant Hospital
ClinicalTrials.gov Identifier:
NCT00947336
First received: July 27, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted

July 27, 2009
July 27, 2009
April 2005
April 2008   (final data collection date for primary outcome measure)
Development of SBP [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Evaluation of Safety & Efficacy of Synbiotic on the Incidence and Recurrence of Spontaneous Bacterial Peritonitis (SBP) in Cirrhotics
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Cirrhosis With Ascites
  • 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.
  • Drug: Norfloxacin + Placebo
    Norfloxacin 400 mg once daily with placebo
  • Active Comparator: Norfloxacin + Synbiotic
    Intervention: Drug: Norfloxacin + Synbiotic
  • Placebo Comparator: Norfloxacin + Placebo
    Intervention: Drug: Norfloxacin + Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
April 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
12 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00947336
2009-PHT-01
Not Provided
Not Provided
Govind Ballabh Pant Hospital
Jhaver Research Foundation Limited
Not Provided
Govind Ballabh Pant Hospital
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP