TerminatedPhase 2

Prevention of Clostridium Difficile-associated Diarrhea by Daily Intake of Kefir

Stopped: Study was not feasible to complete at study site

2 participantsStarted 2015-11

Plain-language summary

This study is being conducted to investigate the potential benefits of probiotic intake for preventing antibiotic associated diarrhea and Clostridium difficile infection in patients undergoing a systemic antibiotic treatment. The primary research question is: can daily intake of kefir, a yogurt-like food containing probiotics, reduce the incidence of diarrhea and Clostridium difficile infection in patients during antibiotic treatment?

Who can participate

Age range

19 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: Patients who have: * Been admitted to the medical unit on 7 West at St. Luke's Hospital (Duluth, MN) * Been prescribed a systemic antibiotic of any kind (administered by oral or parenteral route), but have not yet started the regimen * Consented to be randomized and take part in the study and are adults greater than 19 years of age Exclusion Criteria: Patients who are/have: * Tube feeding * Undergoing dialysis and other renal treatment * An existing C. difficile infection * A recent history of C. difficile infection (within the last 3 months) * A recent history of antibiotic use (within the last 3 months) * Inflammatory bowel disease, Crohn's disease, or other chronic gastrointestinal syndrome * A history of acquired of genetic immunodeficiencies; active, acute or chronic serious infections (i.e., viral hepatitis, HIV/AIDS), or autoimmune disorders * Undergoing gastrointestinal surgery, radiation, or cytotoxic chemotherapy * Allergy to milk protein

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

Incidence of Diarrhea Among the Three Randomized Study Groups Over Time

Timeframe: Assessed daily during hospitalization and daily for up to 30 days post-discharge; data will be represented as an overall incidence of diarrhea for all compliant patients upon study completion (average tracking time per patient is 35 days).

Trial details

NCT IDNCT02707198

SponsorSt. Luke's Hospital of Duluth

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-05-10

Results submitted2021-04-28

View on ClinicalTrials.gov More Clostridium Difficile Infection trials