Effect of Lactobacillus Probiotic on Healthy Adults

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2012

Interventions

  • Biological: Culturelle
    • 10^10 Lactobacillus rhamnosus GG per capsule

Arms, Groups and Cohorts

  • Experimental: 1
    • Lactobacillus rhamnosus GG capsule three times per day while taking their antibiotic(s) and for 7 days following completion of the antibiotic.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of diarrhea
    • Time Frame: Approximately one month

Participating in This Clinical Trial

Inclusion Criteria

  • 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. Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fargo VA Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Stephanie Borchardt, Tze Shien Lo, MD – Fargo VA Medical Center

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