Effect of Lactobacillus Probiotic on Healthy Adults

Fargo VA Medical Center

Status and phase

Completed

Phase 1

Conditions

Antibiotic-associated Diarrhea

Treatments

Biological: Culturelle

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00748748

VERA 437

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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