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| Name | Class |
|---|---|
| Master Supplements, Inc | OTHER |
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We have designed this study to measure the effect of normal flora supplementation, using available probiotics, on the incidence of Clostridium difficile-associated diarrhea
in a population of general inpatients who are receiving antibiotics.
General medical-surgical patients in a community hospital who are receiving antibiotics, and who agree to participate, will be given one of two different probiotics, or placebo. Data will be gathered during their hospitalization, and at one and three months following hospital discharge. We expect to see a lower incidence of Clostridium difficile-associated diarrhea in the probiotic groups when compared to the placebo group. We will also be looking for differences between the effects of the two probiotics, which differ in strain types and number of colony forming units per dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Theralac probiotic | Active Comparator |
| |
| Culturelle probiotic | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Theralac probiotic | Dietary Supplement |
| ||
| Culturelle probiotic |
| Measure | Description | Time Frame |
|---|---|---|
| Development of Clostridium difficile associated diarrhea in patients receiving antibiotics | Up to six months |
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Inclusion Criteria: Any hospitalized patient who is age 19 or older and receiving antibiotics.
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Exclusion Criteria:
Feeding tube in place
Pregnancy
Milk or soy allergy
Sensitivity to lactose
Immunocompromised defined as:
Participants will be withdrawn from the study if they develop any of the exclusion criteria during the hospitalization.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark Middlebrooks, MD | Contact | 205-380-0848 | markmiddlebrooks@bellsouth.net |
| Name | Affiliation | Role |
|---|---|---|
| Leanne Phillips, Pharm.D | St. Vincent's East | Principal Investigator |
| Walter Ross, MD | St. Vincent's East | Principal Investigator |
| Mark Middlebrooks, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent's East | Recruiting | Birmingham | Alabama | 35235 | United States |
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| Dietary Supplement |
|
| placebo | Other |
|
| St. Vincent's East |
| Principal Investigator |
| Lee Wimberly, MD | St. Vincent's East | Principal Investigator |
| Linda Adams, RPh | St. Vincent's East | Principal Investigator |
| Carrie Castleberry, RN | St. Vincent's East | Principal Investigator |