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Effect of Lactobacillus Probiotic on Healthy Adults

NCT ID: NCT00748748

Last Updated: 2012-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-04-30

Brief Summary

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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

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Conditions

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Antibiotic-associated Diarrhea

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

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

Group Type EXPERIMENTAL

Culturelle

Intervention Type BIOLOGICAL

10\^10 Lactobacillus rhamnosus GG per capsule

Interventions

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Culturelle

10\^10 Lactobacillus rhamnosus GG per capsule

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fargo VA Medical Center

FED

Sponsor Role lead

Responsible Party

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Stephanie Borchardt

Tze Shien Lo, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fargo VA Medical Center

Fargo, North Dakota, United States

Site Status

Countries

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United States

Other Identifiers

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VERA 437

Identifier Type: -

Identifier Source: org_study_id