Expired Study
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Cincinnati, Ohio 45244


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT02589964


Primary Contact:

Principal Investigator
Amita Buddhdev, MD
TriHealth Inc.


Backup Contact:

N/A


Location Contact:

Cincinnati, Ohio 45244
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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