Efficacy and Safety of BIO-K + CL1285 in Prevention of Antibiotic-associated Diarrhea in Hospitalized Adult Patients
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diarrhea Clostridium Infections |
Dietary Supplement: Lactobacillus acidophilus CL1285 and Lactobacillus casei Dietary Supplement: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| 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. |
- Efficacy of the product will evaluate the severity and the incidence of AAD, i.e., the presence of blood in the feces, fever, average number of liquid stools per day, and the duration of diarrhea during the episode of AAD. [ Time Frame: March 2006-December 2007 ] [ Designated as safety issue: No ]
- Efficacy of the product will evaluate the incidence of Clostridium difficile in antibiotic associated diarrhea patients [ Time Frame: March 2006- December 2007 ] [ Designated as safety issue: No ]
- Health outcome evaluation will look at the direct medical costs and clinical outcomes of alternative strategies in the prevention of antibiotic-associated diarrhea in hospitalized adult patients [ Time Frame: March 2006- December 2007 ] [ Designated as safety issue: No ]
- Safety will be evaluated on the basis of serious and non-serious adverse events. [ Time Frame: March 2006- December 2007 ] [ Designated as safety issue: Yes ]
| Enrollment: | 472 |
| Study Start Date: | March 2006 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Bio-K Cl1285 Bio-K Cl1285 contains 50 billion of live bacteria.
|
Dietary Supplement: Lactobacillus acidophilus CL1285 and Lactobacillus casei
One bottle daily 2 hours before or after antibiotic administration and for 5 days following the termination of antibiotic regimen.
Other Name: BioK CL1285
|
|
Placebo Comparator: 2
placebo devoid of bacteria
|
Dietary Supplement: placebo
One bottle daily 2 hours before or after antibiotic administration and for 5 days following the termination of antibiotic regimen.
Other Name: placebo
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- presenting to the Emergency Room and considered for admission to hospital for a minimum of 12 hours and requiring antibiotic administration for the treatment of a suspected or proven bacterial infection OR a hospitalized patient developing a suspected or proven nosocomial infection OR an external patient that come to the hospital for repeated visits to receive his intravenous antibiotic therapy for the treatment of a suspected or proven bacterial infection. The external patients on oral antibiotics that come to the hospital for repeated visits to receive any other treatments requiring a hospital stay of more than one hour will also be included.
- Hospital employee on antibiotics can also be included in the study
- having received less than 24 hours of antibiotic therapy;
- requiring a minimum of 3 days and a maximum of 14 days antibiotic administration
Informed consent must be obtained in writing for all subjects at enrollment into the study
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study:
- active diarrhea;
- a history of daily consumption of fermented milk and/or yogurt;
- intolerance to lactose;
- pregnant/breastfeeding women;
- an active, non controlled intestinal disease such as Crohn's Disease or ulcerative colitis;
- ileostomy, jejunostomy or colostomy;
- immunosuppressed state;
- a previous documented C. difficile infection in the three months prior to study initiation;
- active radiotherapy or chemotherapy;
- recent (< 6 months) or planned bone marrow graft or organ transplant;
- antibiotic therapy in the fourteen days prior to study initiation;
- the planned administration of metronidazole (alone or in combination) or vancomycin monotherapy for the treatment of an infection;
- mental or other conditions, or language barriers rendering the subject unable to understand the nature, scope, and possible consequences of the study or complete the self-administered questionnaires;
- subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.
Post-enrollment exclusion criteria include fermented milk and/or yogurt consumption during the study period and two consecutive missed dose of study product.
Contacts and Locations| Canada, Ontario | |
| Hamilton General Hospital | |
| Hamilton, Ontario, Canada, L8L-2X2 | |
| Kingston General Hospital | |
| Kingston, Ontario, Canada, K7L 2V7 | |
| North York General Hospital | |
| Toronto, Ontario, Canada, M2K 1E1 | |
| Canada, Quebec | |
| Hotel Dieu de Chicoutimi | |
| Chicoutimi, Quebec, Canada, G7H5H6 | |
| St-Mary Hospital Center | |
| Montreal, Quebec, Canada, H3T 1M5 | |
| Hotel-Dieu de St-Jerome | |
| St-Jerome, Quebec, Canada, J7Z 5T3 | |
| Centre Hospitalier Régional de Trois-Rivières | |
| Trois-Rivieres, Quebec, Canada, G8Z 3R9 | |
| Canada | |
| Laval Hospital | |
| Quebec, Canada, G1V 4G5 | |
| Principal Investigator: | Joe S Dylewski, MD | St-Mary Hospital Center |
More Information
No publications provided
| Responsible Party: | Dr Joe Dylewski, Microbiologist at St Mary's Hospital |
| ClinicalTrials.gov Identifier: | NCT00328263 History of Changes |
| Other Study ID Numbers: | CL1285-AAD-M01 |
| Study First Received: | May 17, 2006 |
| Last Updated: | February 2, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Bio-K Plus International Inc.:
|
Bio-K+CL1285 Probiotics Antibiotics-associated diarrhea |
Clostridium difficile-associated diarrhea Lactobacillus acidophilus Clostridium Difficile |
Additional relevant MeSH terms:
|
Clostridium Infections Diarrhea Cross Infection Gram-Positive Bacterial Infections Bacterial Infections Signs and Symptoms, Digestive |
Signs and Symptoms Infection Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013