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NCT00748748 Clinical Trial

Effect of Lactobacillus Probiotic on Healthy Adults

Antibiotic-associated Diarrhea Clinical Trial

Official title:
Effect of Lactobacillus Probiotic on Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00748748
Other study ID # VERA 437
Secondary ID
Status Completed
Phase Phase 1
First received September 8, 2008
Last updated July 3, 2012
Start date February 2010
Est. completion date April 2012

Study information
Verified date July 2012
Source Fargo VA Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 64 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Fargo VA Medical Center Fargo North Dakota

Sponsors (1)
Lead Sponsor Collaborator
Fargo VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of diarrhea Approximately one month No
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