Effect of Lactobacillus Probiotic on Healthy Adults
Completed · Phase 1
Conditions studied: Antibiotic-associated Diarrhea
In brief
Diarrhea is a common side effect of antibiotics; it may prolong hospital stay, increase the risk of other infections, develop into more serious forms of disease, and lead to premature discontinuation of the needed antibiotic. The purpose of this study is to examine the safety and effectiveness of a capsule containing Lactobacillus rhamnosus GG in the prevention of diarrhea associated with antibiotic use.
Key facts
- Study ID
- NCT00748748
- Run by
- Fargo VA Medical Center
- People needed
- 20
- Starts
- 2010-02-01
- Expected to finish
- 2012-04-01
- Last updated by the study team
- 2012-07-04
Who can join
Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participants (male or female inpatients) 18 to 64 years of age who are prescribed antibiotics (single or multiple antibiotics, oral or intravenous) will be recruited from the Fargo VAMC Primary Care Clinic area.
- Participants must be able to swallow a capsule.
You may not qualify if…
- Exclusion criteria include diarrhea on admission or within the preceding week
- Reported recurrent diarrhea
- Antibiotics in the past four weeks
- Significant underlying conditions (e.g. diabetes, structural cardiac defects including valvular defects, history of infective endocarditis, poor cardiac function, immunosuppression, impaired gut integrity, moderate or serious intestinal disorders, malignancies, pancreatitis, indwelling catheters, recent surgery, recent prolonged hospitalization)
- Previous bowel surgery
- Nutritional restrictions that preclude participation
- Hypersensitivity to penicillin G, ampicillin, or erythromycin
- Persons who have been prescribed their antibiotic for a duration longer than 3 weeks
Where it is running
- Fargo VA Medical Center — Fargo, North Dakota, United States
Full record on ClinicalTrials.gov
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