Probiotics in the Reduction of Antibiotic Associated Diarrhea

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Probiotics in the Reduction of Antibiotic Associated Diarrhea and Clostridium Difficile in Pneumonia Patients Within a Community Teaching Hospital

Conditions
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Clostridium Difficile

Intervention / Treatment
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* Dietary Supplement: Florajen-3
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted to Good Samaritan Hospital Placed on pneumonia order set Age 18+ Exclusion Criteria: Patient with inadequate coherency to understand consent Active Diarrhea at admission Non-controlled intestinal disease Documented positive C. difficile infection within the 3 months before enrollment Antibiotic use at hospital admission Immunosuppressive therapy Pregnancy Allergic to ingredients in Florajen-3 Allergic to ingredients in placebo Immunocompromised state including: HIV with a low CD4 count Active malignancy receiving chemotherapy Medications including long-term steroids (>2 weeks), and disease modifying biologic agents Acquired immune deficiency Unable to take oral medication Less than 4 doses of probiotic or placebo Taking probiotic in the past 30 days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotic<br>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 | Dietary Supplement: Florajen-3<br>* 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.<br>* Other names: probiotic;|
| Placebo Comparator: Placebo<br>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 | Other: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay |  | during hospitalization up to 4 weeks | 
| Mortality |  | During hospitalization up to 4 weeks | 
| Healthcare costs | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotics, antibiotic associated diarrhea, clostridium difficile