Effect of Lactobacillus Probiotic on Healthy Adults

Phase 1

Completed

• Conditions: Antibiotic-associated Diarrhea
• Interventions: Biological: Culturelle

• Registration Number: NCT00748748
• Lead Sponsor: Fargo VA Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-08
• Study First Submitted QC: 2008-09-08
• Study First Posted: 2008-09-09
• Study Start: 2010-02
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-03
• Last Update Posted: 2012-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Culturelle	Lactobacillus rhamnosus GG capsule three times per day while taking their antibiotic(s) and for 7 days following completion of the antibiotic.

Primary Outcome Measures

Name	Time	Method
Incidence of diarrhea	Approximately one month

Trial Locations

Locations (1)

Fargo VA Medical Center; 🇺🇸 Fargo, North Dakota, United States