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 range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To evaluate the incidence of Clostridium Difficile infection

Timeframe: 2 Years

Trial details

NCT IDNCT01972932

SponsorBio-K Plus International Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-11

View on ClinicalTrials.gov More Clostridium Difficile Infection trials