Probiotics in the Reduction of Antibiotic Associated Diarrhea

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Clostridium Difficile

In brief

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.

Key facts

Study ID

NCT02589964

Run by

TriHealth Inc.

People needed

1

Starts

2015-03-01

Expected to finish

2015-07-01

Last updated by the study team

2016-10-31

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Admitted to Good Samaritan Hospital
• Placed on pneumonia order set
• Age 18+

You may not qualify if…

• 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

Where it is running

• TriHealth — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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