Effect of Probiotic on Antibiotic-Associated Diarrhea - Full Text View

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 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 Other: Inulin	Phase III

MedlinePlus related topics:

Antibiotics Diarrhea

Drug Information available for:

Inulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	Effect of Lactobacillus Probiotic on Antibiotic-Associated Diarrhea

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 ]

Estimated Enrollment:	200
Study Start Date:	October 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Placebo Comparator Inulin capsule three times per day while taking their antibiotic(s) and for 7 days following completion of the antibiotic.	Other: Inulin

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Participants (male or female inpatients) ≥18 years of age who are prescribed antibiotics (single or multiple antibiotics, oral or intravenous) will be recruited from the Fargo VAMC medical, surgical, and intensive care units, and the community living center.
Participants must be able to swallow a capsule or a suspension containing the contents of the capsule.

Exclusion Criteria:

Exclusion criteria include diarrhea on admission or within the preceding week
Reported recurrent diarrhea
Antibiotics in the past four weeks
Severe life threatening illness
Previous bowel surgery
Nutritional restrictions that preclude participation

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Fargo VA Medical Center ( Stephanie Borchardt, Research Coordinator )
Study ID Numbers:	VERA 437
First Received:	September 8, 2008
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00748748
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms

Diarrhea

Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 05, 2008

Sponsored by:	Fargo VA Medical Center
Information provided by:	Fargo VA Medical Center
ClinicalTrials.gov Identifier:	NCT00748748