Lactobacillus Reuteri in the Prevention of Antibiotic Associated-diarrhea and Clostridium Difficile (NCT02127814) | Clinical Trial Compass
CompletedNot Applicable
Lactobacillus Reuteri in the Prevention of Antibiotic Associated-diarrhea and Clostridium Difficile
United States73 participantsStarted 2010-05
Plain-language summary
The purpose of this study is to find whether Lactobacillus reuteri prevents antibiotic-associated diarrhea and related Clostridium difficile infections. Subjects will be admitted from the University Hospitals Case Medical Center. They will be randomly assigned to an intervention group receiving L. reuteri or a placebo. Supplementation will occur during antibiotic treatment and for an additional 7 days after cessation of treatment. Data collection will occur at baseline, end of antibiotic use, 7 days after antibiotic cessation, and 21 days after antibiotic cessation. Primary data includes diarrhea instances. Secondary data includes severity of diarrhea, presence of C. difficile toxins, and presence of other GI symptoms.
Who can participate
Age range
18 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:
* Receiving antibiotics for not more than 48 hours prior to enrollment and free from diarrhea
* able to understand and sign informed consent and HIPPA
* available throughout the study period
* subjects should have the mental ability to understand and willingness to fulfill all the details of the protocol
Exclusion Criteria:
* three or more soft and unformed or watery stools per day at admission
* receiving chemotherapy or radiation therapy
* diagnosis of inflammatory bowel disease
* NPO without PO meds
* neutropenia (an absolute neutrophil count (ANC) of less than 1500/microL)
* HIV positive with a CD4+ T-lymphocyte count \<400 per mcL blood
* requiring care in an intensive care unit
* status-post bowel resection during hospitalization
* patient's receiving antibiotics four weeks prior to hospitalization
* patient with severe life threatening illness or immunocompromised
* pregnancy
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.