Study of Bio-K+® in the Reduction of the Risk of Clostridium Difficile Infection and Antibiotic A… (NCT01972932) | Clinical Trial Compass
TerminatedPhase 4
Study of Bio-K+® in the Reduction of the Risk of Clostridium Difficile Infection and Antibiotic Associated Diarrhea
Stopped: Recruitment problems
Canada60 participantsStarted 2013-11
Plain-language summary
Antibiotic-associated diarrhea (AAD) and particularly Clostridium difficile-Infection (CDI) are the most common causes of healthcare associated infectious diarrhea. In light of the results obtained in a limited number of randomized clinical trials in subjects with AAD and CDI in comparison with the widespread occurrence of these diseases, it is felt that the addition of a well-controlled clinical trial in a western environment would add value to support the use of a specific probiotic to counteract these diseases.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion Criteria
Only subjects who meet the following inclusion criteria will be eligible to participate in the study:
* Are at least 18 years old
* Able to tolerate food intake Antibiotic treatment started less than 48hrs from admission into the study
* Have an expected hospitalization period of at least three days (including subject"s stay in the emergency room)
* Speak and understand English and/or French.
* Have an expected survival greater than 60 days
* Agree to refrain from taking probiotic products (besides the study drug) during the study period Have given informed consent In addition, women of child bearing capacity who are not pregnant at the moment of screening (pregnancy test done on-site) and agree to use an acceptable form of birth control for the duration of the study (e.g. Condom, oral contraceptives, etc.) are allowed to participate.
Exclusion Criteria
Subjects who meet any of the following exclusion criteria will not be eligible to participate in the study:
* Have been diagnosed with CDI in previous sixty days
* Have taken Streptomycin, oral Vancomycin, or Metronidazole in the last 4 weeks, excluding as part of the treatment regimen triggering their inclusion into the study.
* Are currently suffering from any health condition causing immunosuppression (including haematological malignancies, lymphoma, AIDS, transplant, and hemodialysis)
* Have received more than 10 mg of prednisone per day for at least 1 month within 3 months prior to the participatio…
What they're measuring
1
To evaluate the incidence of Clostridium Difficile infection