Effect of Lactobacillus Probiotic on Healthy Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stephanie Borchardt, Fargo VA Medical Center
ClinicalTrials.gov Identifier:
NCT00748748
First received: September 8, 2008
Last updated: July 3, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Antibiotic-associated Diarrhea
Biological: Culturelle
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Lactobacillus Probiotic on Healthy Adults

Resource links provided by NLM:


Further study details as provided by Fargo VA Medical Center:

Primary Outcome Measures:
  • Incidence of diarrhea [ Time Frame: Approximately one month ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: February 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00748748

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

No publications provided

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
Study First Received: September 8, 2008
Last Updated: July 3, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 28, 2014