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

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ClinicalTrials.gov Identifier: NCT00947336
Recruitment Status : Completed
First Posted : July 28, 2009
Last Update Posted : July 28, 2009
Sponsor:
Collaborator:
Jhaver Research Foundation Limited
Information provided by:
Govind Ballabh Pant Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Cirrhosis With Ascites Drug: Norfloxacin + Synbiotic Drug: Norfloxacin + Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
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
Study Start Date : April 2005
Primary Completion Date : April 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Development of SBP [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00947336


Locations
India
Department of Gastroenterology, G B Pant Hospital
New Delhi, Delhi, India, 110002
Sponsors and Collaborators
Govind Ballabh Pant Hospital
Jhaver Research Foundation Limited

ClinicalTrials.gov Identifier: NCT00947336     History of Changes
Other Study ID Numbers: 2009-PHT-01
First Posted: July 28, 2009    Key Record Dates
Last Update Posted: July 28, 2009
Last Verified: July 2009

Additional relevant MeSH terms:
Recurrence
Ascites
Peritonitis
Disease Attributes
Pathologic Processes
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases
Norfloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors