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Low Recruitment
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The study will evaluate the effectiveness of probiotic therapy in reducing the incidence of antibiotic associated diarrhea (AAD) and Clostridium difficile associated diarrhea (CDAD) in pneumonia patients.
The study will include patients admitted to Good Samariatan Hospital and placed on the pneumonia order set. After obtaining consent, subjects will be randomized to the proboiotic or placebo group. Subjects will be followed for 21 days after starting the study treatment to determine critical outcomes such as incidence of antibiotic-associated diarrhea and C-Diff. Other outcomes include length of stay, healthcare costs, and death.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Active Comparator | Treatment will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days. The treatment is Florajen-3. The ingredients in Florajen-3 are: Lactobacillus acidophilus-over 7.5 billion Bifidobacterium lactis-over 6.0 billion Bifidobacterium longum-over 1.5 billion |
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| Placebo | Placebo Comparator | Placebo will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days. The ingredients in the placebo are: Rice maltodextrin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Florajen-3 | Dietary Supplement | The probiotic treatment is the experimental aspect of the study. Treatment will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Antibiotic Associated Diarrhea | Subjects will be asked to keep a diary for 20 days after starting study treatment and will be contacted by a nurse approximately 21 days after starting study treatment | 21 days after starting study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay | during hospitalization up to 4 weeks | |
| Mortality | During hospitalization up to 4 weeks | |
| Healthcare costs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amita Buddhdev, MD | TriHealth Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TriHealth | Cincinnati | Ohio | 45244 | United States |
The study was closed due to poor recruitment, so there is no data to share.
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo | Other | The placebo treatment is the experimental aspect of the study. Treatment will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days. |
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Healthcare costs include direct costs during hospital stay (room, meds, procedures). This is obtained through the TriHealth Decision Support department. |
| During hospitalization up to 4 weeks |
| Clostridium difficile | Data is obtained though a follow-up call to the patient. | 21 days after initiating study treatment |
| D019602 |
| Food and Beverages |