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Clinical Trial Summary

We have designed this study to measure the effect of normal flora supplementation, using available probiotics, on the incidence of Clostridium difficile-associated diarrhea

in a population of general inpatients who are receiving antibiotics.


Clinical Trial Description

General medical-surgical patients in a community hospital who are receiving antibiotics, and who agree to participate, will be given one of two different probiotics, or placebo. Data will be gathered during their hospitalization, and at one and three months following hospital discharge. We expect to see a lower incidence of Clostridium difficile-associated diarrhea in the probiotic groups when compared to the placebo group. We will also be looking for differences between the effects of the two probiotics, which differ in strain types and number of colony forming units per dose. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms

  • Development of Clostridium Difficile Associated Diarrhea
  • Diarrhea

NCT number NCT01873872
Study type Interventional
Source St. Vincent's East, Birmingham, Alabama
Contact Mark Middlebrooks, MD
Phone 205-380-0848
Email markmiddlebrooks@bellsouth.net
Status Recruiting
Phase N/A
Start date July 2013
Completion date March 2014