Probiotics for Clostridium Difficile Infection in Older Adults
Completed · Phase 2 · Has a placebo group
Conditions studied: Clostridium Difficile
In brief
The purpose of this study is to determine whether a probiotic, when used together with standard treatment, is effective in reducing duration of symptoms and preventing recurrence of infection in older adults with a first episode of C. difficile infection.
Key facts
- Study ID
- NCT01680874
- Run by
- University of Wisconsin, Madison
- People needed
- 33
- Starts
- 2013-02-01
- Expected to finish
- 2015-02-01
- Last updated by the study team
- 2015-12-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult of either gender, 18 years or older with a first episode of C. difficile infection
- Meets the case definition of C. difficile infection-diarrhea associated with a positive stool test for C. difficile toxin(s) in the 2 days prior to enrollment treated with metronidazole or vancomycin
You may not qualify if…
- Severe disease defined as any of the following: WBC > 30,000 or < 1000 cells/mm\^3, elevated creatinine > 1.5 times the premorbid level, ICU patient at time C. difficile infection diagnosed
- Has other known etiology of diarrhea (e.g. other enteric pathogen, other intestinal disease)
- Has a history of chronic intestinal disease (e.g. Crohn's disease, ulcerative colitis)
- Has a presence of toxic megacolon or ileus
- Has a presence of colostomy or nasogastric tube
- Has a history of abdominal surgery within the previous 3 months (from time of enrollment)
- Is enrolled in another investigational drug trial
- Is unavailable for follow-up visits
- History of multiple C. difficile infection
- Willing not to take other probiotics for duration of study
- Is severely immunocompromised.
Where it is running
- University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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