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Search / Trial NCT02589964

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

Probiotics Antibiotic Associated Diarrhea Clostridium Difficile

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.

Locations

Cincinnati, Ohio, United States

Patients applied

0 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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