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Effect of Lactobacillus Probiotic on Healthy Adults

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ClinicalTrials.gov Identifier: NCT00748748
Recruitment Status : Completed
First Posted : September 9, 2008
Last Update Posted : July 4, 2012
Sponsor:
Information provided by (Responsible Party):
Stephanie Borchardt, 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.

Condition or disease Intervention/treatment Phase
Antibiotic-associated Diarrhea Biological: Culturelle Phase 1

Study Type : Interventional  (Clinical Trial)
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 : February 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Incidence of diarrhea [ Time Frame: Approximately one month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00748748


Locations
United States, North Dakota
Fargo VA Medical Center
Fargo, North Dakota, United States, 58102
Sponsors and Collaborators
Fargo VA Medical Center

Responsible Party: Stephanie Borchardt, Tze Shien Lo, MD, Fargo VA Medical Center
ClinicalTrials.gov Identifier: NCT00748748     History of Changes
Other Study ID Numbers: VERA 437
First Posted: September 9, 2008    Key Record Dates
Last Update Posted: July 4, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms