Lactobacillus Reuteri in the Prevention of Antibiotic Associated-diarrhea and Clostridium Difficile
Completed · Not applicable · Has a placebo group
Conditions studied: Antibiotic-associated Diarrhea, Clostridium Difficile
In brief
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.
Key facts
- Study ID
- NCT02127814
- Run by
- Case Western Reserve University
- People needed
- 73
- Starts
- 2010-05-01
- Expected to finish
- 2017-12-31
- Last updated by the study team
- 2019-01-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University Hospitals Case Medical Center — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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