Effect of Lactobacillus Probiotic on Healthy Adults

Last updated: July 3, 2012
Sponsor: Fargo VA Medical Center
Overall Status: Completed

Phase

1

Condition

Bowel Dysfunction

Stomach Discomfort

Clostridium Difficile-associated Diarrhea

Treatment

N/A

Clinical Study ID

NCT00748748
VERA 437
  • Ages 18-64
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants (male or female inpatients) 18 to 64 years of age who are prescribedantibiotics (single or multiple antibiotics, oral or intravenous) will be recruitedfrom the Fargo VAMC Primary Care Clinic area.

  • Participants must be able to swallow a capsule.

Exclusion

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 includingvalvular defects, history of infective endocarditis, poor cardiac function,immunosuppression, impaired gut integrity, moderate or serious intestinal disorders,malignancies, pancreatitis, indwelling catheters, recent surgery, recent prolongedhospitalization)

  • 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

Study Design

Total Participants: 20
Study Start date:
February 01, 2010
Estimated Completion Date:
April 30, 2012

Connect with a study center

  • Fargo VA Medical Center

    Fargo, North Dakota 58102
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.