Probiotics in the Reduction of Antibiotic Associated Diarrhea



Status:Terminated
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 120
Updated:4/21/2016
Start Date:March 2015
End Date:July 2015

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

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.

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
We found this trial at
1
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Cincinnati, Ohio 45220
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Cincinnati, OH
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