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Effect of Lactobacillus Probiotic on Healthy Adults

Primary Purpose

Antibiotic-associated Diarrhea

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Culturelle
Sponsored by
Fargo VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Antibiotic-associated Diarrhea

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Fargo VA Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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

Outcomes

Primary Outcome Measures

Incidence of diarrhea

Secondary Outcome Measures

Full Information

First Posted
September 8, 2008
Last Updated
July 3, 2012
Sponsor
Fargo VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00748748
Brief Title
Effect of Lactobacillus Probiotic on Healthy Adults
Official Title
Effect of Lactobacillus Probiotic on Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fargo VA Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antibiotic-associated Diarrhea

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Lactobacillus rhamnosus GG capsule three times per day while taking their antibiotic(s) and for 7 days following completion of the antibiotic.
Intervention Type
Biological
Intervention Name(s)
Culturelle
Intervention Description
10^10 Lactobacillus rhamnosus GG per capsule
Primary Outcome Measure Information:
Title
Incidence of diarrhea
Time Frame
Approximately one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fargo VA Medical Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58102
Country
United States

12. IPD Sharing Statement

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Effect of Lactobacillus Probiotic on Healthy Adults

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