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
  Purpose

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 Intervention Phase
Cirrhosis With Ascites
Drug: Norfloxacin + Synbiotic
Drug: Norfloxacin + Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Govind Ballabh Pant Hospital:

Primary Outcome Measures:
  • Development of SBP [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 110
Study Start Date: April 2005
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00947336     History of Changes
Other Study ID Numbers: 2009-PHT-01
Study First Received: July 27, 2009
Last Updated: July 27, 2009
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Ascites
Liver Cirrhosis
Fibrosis
Peritonitis
Recurrence
Pathologic Processes
Liver Diseases
Digestive System Diseases
Peritoneal Diseases
Disease Attributes
Norfloxacin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014