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The site is unable to recruit patients.
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| Name | Class |
|---|---|
| Sprim Advanced Life Sciences | OTHER |
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The primary objective of this study is to evaluate the efficacy of BIO-K+ CL1285 for prevention of recurrent Clostridium difficile infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | BIO-K+ CL1285 |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus acidophilus CL1285® and Lactobacillus casei | Dietary Supplement | 2 capsules of Lactobacillus acidophilus CL1285® and Lactobacillus casei (50 billion cfu/capsule), consumed once daily for 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of recurrent Clostridium difficile infection | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of recurrent diarrhea episodes | 60 days | |
| Presence of gastrointestinal symptoms | 60 days | |
| Adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cornelius J Foley, MD | Parker Jewish for Health Care and Rehabilitation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parker Jewish Institute | New Hyde Park | New York | 11040 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20145608 | Background | 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. |
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| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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|
| Placebo | Dietary Supplement | 2 capsules of placebo (no live cells), consumed once daily for 60 days |
|
| 60 days |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |