Effect of Lactobacillus Probiotic on Healthy Adults

Sponsor

Fargo VA Medical Center (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00748748

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Antibiotic-associated Diarrhea	Biological: Culturelle	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Effect of Lactobacillus Probiotic on Healthy Adults

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Lactobacillus rhamnosus GG capsule three times per day while taking their antibiotic(s) and for 7 days following completion of the antibiotic.	Biological: Culturelle 10^10 Lactobacillus rhamnosus GG per capsule

Arm

Intervention/Treatment

Experimental: 1

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

Biological: Culturelle

10^10 Lactobacillus rhamnosus GG per capsule

Outcome Measures

Primary Outcome Measures

Incidence of diarrhea [Approximately one month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fargo VA Medical Center	Fargo	North Dakota	United States	58102

Sponsors and Collaborators

Fargo VA Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stephanie Borchardt, Tze Shien Lo, MD, Fargo VA Medical Center

ClinicalTrials.gov Identifier:

NCT00748748

Other Study ID Numbers:

VERA 437

First Posted:

Sep 9, 2008

Last Update Posted:

Jul 4, 2012

Last Verified:

Jul 1, 2012

Additional relevant MeSH terms:

Diarrhea

Study Results

No Results Posted as of Jul 4, 2012