Phase 3
N=255
Efficacy and Safety Study in the Prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridium Difficile-Associated Diarrhea (CDAD) in Hospitalized Adult Patients Exposed to Nosocomial Infection
Antibiotic-Associated Diarrhea · Clostridium Difficile-Associated Diarrhea
Bottom Line
View on ClinicalTrials.gov: NCT00958308 ↗Enrolled (actual)
255
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcome: Primary: To Assess if Probiotic Prophylaxis (BIO-K+CL1285®) is Effective for the Prevention of AAD in Hospitalized Patients. — 84; 85; 86 participants — p==0.02
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- BIO-K+ CL-1285® (Other); Placebo (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Bio-K Plus International Inc.
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Assess if Probiotic Prophylaxis (BIO-K+CL1285®) is Effective for the Prevention of AAD in Hospitalized Patients. |
84; 85; 86 | =0.02 sig |
| SECONDARY Severity of AAD in Hospitalized Patients Ingesting BIO-K+CL1285® or Placebo. |
— | — |
| SECONDARY Frequency of Stool Samples Positive for Clostridium Difficile (C. Difficile) Toxin A and/or B. |
— | — |
| SECONDARY Safety Profile of BIO-K+CL1285® Versus Placebo in Hospitalized Patients. |
— | — |
| SECONDARY Frequencies of Other Gastrointestinal Symptoms. |
— | — |
Summary
The purpose of this study is to evaluate the efficacy and safety of Bio-K+ CL-1285 in the prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridum difficile-Associated Diarrhea (CDAD) in hospitalized patients exposed to nosocomial infection.
Eligibility Criteria
Inclusion Criteria
- Antibiotic therapy for a minimum of 3 days and a maximum of 14 days
- Expected to remain hospitalized for a minimum of 5 days
- Patients who have received less than 36 hours of antibiotic therapy
- Negative pregnancy test at screening
- Obtained his/her informed consent after verbal and written information
- Patients having a telephone available (mobile, work, home)
- Patients having a fridge at home
Exclusion Criteria
- Pregnant or breastfeeding women
- Patients presenting with active diarrhea (3 or more liquid stools per 24 hour period).
- Patients with a history of daily consumption of probiotics, fermented milk and/or yogurt;
- Patients known to have shown a previous reaction, including anaphylaxis, to any substance in composition of the study product (i.e. Non-medicinal ingredients: Cellulose, hypromellose, magnesium stearate (vegetal source), ascorbic acid, Colloidal silicon dioxide)
- Patients presenting with an active, non-controlled intestinal disease such as Crohn's Disease or ulcerative colitis;
- A previous documented C. Difficile infection < 3 months prior to study initiation ;
- Ostomized patients, parenteral nutrition users
- Patients with an immunosuppressive therapy or any health condition causing immunosuppression (including haematological malignancies, acquired immune deficiency syndrome (AIDS))
- Ongoing or recent use of antibiotic therapy in the 30 days prior to the study product first administration.
- Patients with planned administration of antibiotics other than broad spectrum Penicillin, Cephalosporin or Clindamycin for the treatment of an infection;
- Patients with concomitant participation in another clinical trial;
- Patients who are not likely to comply with study requirements
Data sourced from ClinicalTrials.gov (NCT00958308). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.