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| ID | Type | Description | Link |
|---|---|---|---|
| CL 1285-AAD-CH01 |
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| Name | Class |
|---|---|
| Sprim Advanced Life Sciences | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Two capsules of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention. |
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| BIO-K+ CL-1285 | Active Comparator | Two probiotic capsules (BIO-K+ CL-1285®) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention. |
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| BIO-K+ CL-1285® & placebo | Other | One probiotic capsule (BIO-K+ CL-1285®) and one placebo capsule (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIO-K+ CL-1285® | Other | A mixture of Lactobacillus acidophilus and Lactobacillus casei, contains over 50 billion living bacteria per administered dose. |
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| Measure | Description | Time Frame |
|---|---|---|
| To Assess if Probiotic Prophylaxis (BIO-K+CL1285®) is Effective for the Prevention of AAD in Hospitalized Patients. | Incidence of AAD data were collected using questionnaire and diaries given to participants upon discharge. Diagnosis of AAD was made when a patient produced three or more liquid stools in a 24h period after antibiotic treatment with no other obvious reason for diarrhea. | Up to 40 days |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of AAD in Hospitalized Patients Ingesting BIO-K+CL1285® or Placebo. | Duration of diarrhea was determined by number of continuous days of diarrhea. Average number of liquid stools per day was determined by the sum of the number of liquid stools per day in the AAD episode divided by the duration of diarrhea in days. | Up to 40 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gao XingWang, MD | Xinhua/Yuyao Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20145608 | Result | Gao XW, Mubasher M, Fang CY, Reifer C, Miller LE. Dose-response efficacy of a proprietary probiotic formula of Lactobacillus acidophilus CL1285 and Lactobacillus casei LBC80R for antibiotic-associated diarrhea and Clostridium difficile-associated diarrhea prophylaxis in adult patients. Am J Gastroenterol. 2010 Jul;105(7):1636-41. doi: 10.1038/ajg.2010.11. Epub 2010 Feb 9. |
| Label | URL |
|---|---|
| Dose-response probiotic study for AAD and CDAD | View source |
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Inclusion & exclusion criterias were used to randomized patients.
1120 patients screened, 255 enrolled at the Xinhua/Yuyao Hospital, Shangai Jiao Tong University, China between Oct. 2008 and March 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Two capsules of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention. |
| FG001 | BIO-K+ CL-1285® & Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Other | Placebo is devoid of microorganisms. |
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| Frequency of Stool Samples Positive for Clostridium Difficile (C. Difficile) Toxin A and/or B. |
If diarrhea occured while hospitalized, patients provided a stool sample for C. difficile analysis of Toxin A and/or B. All episodes were recorded by a nurse of clinician on a case report form using the seven-item Bristol Stool Form Scale (Riegler et al., 2001). A diarrhea episode was described as a bowel movement consisting of watery stool with or without solids. |
| Up to 40 days |
| Safety Profile of BIO-K+CL1285® Versus Placebo in Hospitalized Patients. | Adverse events were reported by patients in the three study groups. | Up to 40 days |
| Frequencies of Other Gastrointestinal Symptoms. | Episodes of gastrointestinal disorders during hospitalization were recorded by patient interview and were confirmed by review of patient diaries. | Up to 40 days |
One capsule of probiotic (BIO-K+ CL-1285® with 50 billion colony forming units (CFU)) and one capsule of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention. |
| FG002 | BIO-K+ CL-1285 | Two capsules of probiotic(BIO-K+ CL-1285® - each capsule contains 50 billion CFU) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Two capsules of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention. |
| BG001 | BIO-K+ CL-1285® & Placebo | One capsule of probiotic (BIO-K+ CL-1285® with 50 billion colony forming units (CFU)) and one capsule of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention. |
| BG002 | BIO-K+ CL-1285 | Two capsules of probiotic(BIO-K+ CL-1285® - each capsule contains 50 billion CFU) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | To Assess if Probiotic Prophylaxis (BIO-K+CL1285®) is Effective for the Prevention of AAD in Hospitalized Patients. | Incidence of AAD data were collected using questionnaire and diaries given to participants upon discharge. Diagnosis of AAD was made when a patient produced three or more liquid stools in a 24h period after antibiotic treatment with no other obvious reason for diarrhea. | Posted | Number | participants | Up to 40 days |
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| Secondary | Severity of AAD in Hospitalized Patients Ingesting BIO-K+CL1285® or Placebo. | Duration of diarrhea was determined by number of continuous days of diarrhea. Average number of liquid stools per day was determined by the sum of the number of liquid stools per day in the AAD episode divided by the duration of diarrhea in days. | Not Posted | Up to 40 days | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Frequency of Stool Samples Positive for Clostridium Difficile (C. Difficile) Toxin A and/or B. | If diarrhea occured while hospitalized, patients provided a stool sample for C. difficile analysis of Toxin A and/or B. All episodes were recorded by a nurse of clinician on a case report form using the seven-item Bristol Stool Form Scale (Riegler et al., 2001). A diarrhea episode was described as a bowel movement consisting of watery stool with or without solids. | Not Posted | Up to 40 days | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Safety Profile of BIO-K+CL1285® Versus Placebo in Hospitalized Patients. | Adverse events were reported by patients in the three study groups. | Not Posted | Up to 40 days | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Frequencies of Other Gastrointestinal Symptoms. | Episodes of gastrointestinal disorders during hospitalization were recorded by patient interview and were confirmed by review of patient diaries. | Not Posted | Up to 40 days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Placebo | Two capsules of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention. | 0 | 84 | 2 | 84 | ||
| EG001 | BIO-K+ CL-1285® & Placebo | One capsule of probiotic (BIO-K+ CL-1285® with 50 billion colony forming units (CFU)) and one capsule of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention. | 0 | 85 | 0 | 85 | ||
| EG002 | BIO-K+ CL-1285 | Two capsules of probiotic(BIO-K+ CL-1285® - each capsule contains 50 billion CFU) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention. | 0 | 86 | 1 | 86 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Fever and hematochezia | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Serge Carrière | Bio-K+ International. Inc. | 450-978-2465 | scarriere@biokplus.com |
| Male |
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