Clinical Trials Logo
  1. Home
  2. Clostridium Infections
  3. NCT00328263

Efficacy and Safety of BIO-K + CL1285 in Prevention of Antibiotic-associated Diarrhea in Hospitalized Adult Patients

Diarrhea Clinical Trial

Official title:
A Double-blind, Randomized, Placebo Controlled, Multicenter Study of the Efficacy and Safety of BIO-K*+ CL-1285* in the Prevention of Antibiotic-associated Diarrhea in Adult Patients Exposed to Nosocomial Infection.

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of Bio-K + CL1285 versus placebo in the prevention of antibiotic-associated diarrhea in hospitalized adult patients.

Clinical Trial Description

Antibiotic-associated diarrhea (AAD) is one of the most frequent adverse events following antibiotherapy and is the leading cause of diarrhea in hospitalized patients. Ten to 25% of AAD are caused by the bacteria Clostridium difficile.

A recent unicenter study conducted at Maisonneuve-Rosemont hospital demonstrated the preventive role of Bio-K + CL1285 in antibiotic-associated diarrhea and Clostridium difficile-associated diarrhea. Its preventive role is thought to be mainly through restoration of the gastrointestinal flora affected in part by the antibiotherapy.

A wide body of literature reveals clinical use of probiotics, but few well controlled prospective studies conducted on large numbers of subjects have been performed.

In light of the positive preliminary results obtained in a limited number of patients with AAD and of the paucity of well controlled clinical trials, we now wish to undertake a randomized, double blind, multicentre study to evaluate the efficacy and safety of Bio-K + CL1285 prophylaxis vs. placebo in the prevention of antibiotic-associated diarrhea in hospitalized adult patients. As secondary objectives, we also intend to evaluate the incidence of Clostridium difficile-associated diarrhea and to demonstrate that BIO-K + CL1285 agent will not only improve the clinical outcomes but also reduce health care expenditures. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00328263
Study type Interventional
Source Bio-K Plus International Inc.
Contact
Status Completed
Phase Phase 3
Start date March 2006
Completion date October 2007
View Details
See also
  Status Clinical Trial Phase
Completed NCT06283784 - Study To Evaluate The Efficacy of a Proprietary Mix of Live Probiotics In The Prophylaxis Of Diarrhea In Adult Patients N/A
Recruiting NCT03851835 - Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis Phase 3
Completed NCT04003181 - The Pathogenesis of Chronic Diarrhoea After Treatment for Cancer in Cecum and the Ascending Colon N/A
Completed NCT03596827 - The Protective Immune Response to Attenuated Enterotoxigenic Escherichia Coli Infection N/A
Recruiting NCT05372068 - Cement flooRs AnD chiLd hEalth (CRADLE) N/A
Completed NCT03972618 - Evaluation of the Efficacy of Sawyer Point One Filters in Schools and Homes in the Dominican Republic N/A
Completed NCT05207618 - Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant N/A
Not yet recruiting NCT05052489 - Registry and Clinical Observation of Children With Diarrhoeal Disease
Completed NCT02541695 - Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli N/A
Completed NCT02428647 - Lao Zinc Study: Effects of Two Forms of Daily Preventive Zinc Versus Therapeutic Zinc Supplementation N/A
Completed NCT02197780 - Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD N/A
Completed NCT01739231 - Live Attenuated ETEC Vaccine ACE527 With and Without dmLT Adjuvant in Adults Phase 1/Phase 2
Completed NCT01968408 - Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children Phase 3
Completed NCT01438645 - ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy N/A
Completed NCT01371656 - Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation Phase 3
Not yet recruiting NCT01382199 - Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients Phase 3
Terminated NCT01048567 - Efficacy and Safety of Lactobacillus Acidophilus/Rhamnosus Combination for the Prevention of Antibiotic-associated Diarrhea in the Elderly Phase 2
Terminated NCT01472211 - Water-based Zinc Intervention Trial in Zinc Deficient Children Phase 0
Completed NCT00914225 - Effect of Bednets and a Water Purification Device on HIV Disease Progression Among ART naïve Patients in Kenya N/A
Completed NCT00760851 - Yogurt Study in Children 2-4 Years Old Attending Daycare Phase 3