NCT02589964

Probiotics in the Reduction of Antibiotic Associated Diarrhea

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: TriHealth Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Clostridium Difficile

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Florajen-3	The probiotic treatment is the experimental aspect of the study. Treatment will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days.
OTHER	Placebo	The placebo treatment is the experimental aspect of the study. Treatment will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days.

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2015-10-28
• Last updated: 2016-10-31

Locations

1 site across 1 country: United States