Probiotics in the Reduction of Antibiotic Associated Diarrhea
Launched by TRIHEALTH INC. · Oct 27, 2015
Trial Information
Current as of June 18, 2025
Terminated
Keywords
ClinConnect 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.
Gender
ALL
Eligibility 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
About Trihealth Inc.
TriHealth Inc. is a leading integrated healthcare system dedicated to enhancing the health and well-being of the communities it serves. Committed to innovation and excellence in patient care, TriHealth conducts clinical trials to advance medical knowledge and improve treatment options across various health conditions. With a focus on collaboration and research integrity, TriHealth partners with healthcare professionals and institutions to facilitate groundbreaking studies that contribute to evidence-based practices and the development of new therapies. Their comprehensive approach ensures that patient safety and ethical standards remain at the forefront of all clinical research initiatives.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cincinnati, Ohio, United States
Patients applied
Trial Officials
Amita Buddhdev, MD
Principal Investigator
TriHealth Inc.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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