Effect of Probiotic Lactobacilli (Lacidofil Cap®) for the Prevention of Antibiotic-Associated Diarrhea
Antibiotic-Associated Diarrhea (AAD) is a common complication of antibiotic use. The frequency of AAD can be high (26 - 60%) or moderate (13-29%) during hospital outbreaks and is relatively infrequent in outpatients. The risk factors for AAD include broad-spectrum antibiotics, host factors (age, health status, and gender), hospitalization period and exposure to nosocomial pathogens. AAD occurs 2-8 weeks after exposure to antibiotics as a result of disrupting normal intestinal microflora. One of the roles of normal intestinal microflora is to act as a protective barrier that resists the colonization of intestinal pathogens. These patients are susceptible to infection by opportunistic pathogens without this protective barrier. Probiotic therapy is suited to AAD and Clostridium difficile disease. Probiotics assist in reestablishing the disrupted intestinal microflora, enhancing immune responses and clearing pathogens and their toxins from the host. Studies using probiotics have been reported for the past twenty-eight years (1977~2005), but the studies have been variable in trial designs and types of probiotics, had differing doses and durations of treatment, and thus have yielded controversial results. The investigators will conduct a multi-center, randomized, placebo-controlled, double-blind trial to assess the efficacy of the probiotic Lactobacilli (Lacidofil cap®) for the prevention of AAD in adults.
Antibiotics Associated Colitis
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Effect of Probiotic Lactobacilli (Lacidofil Cap®) for the Prevention of Antibiotic-Associated Diarrhea: Prospective, Randomized Double-blind, Multicenter Study|
- Presence of AAD [ Time Frame: Up to 14 days ] [ Designated as safety issue: No ]AAD defined as: Watery stools more than 3 times per day for at least 2 days.
- Presence of Bowel Habit Change (Watery Stools More Than 2 Times Per Day for at Least 2 Days) [ Time Frame: Up to14 days ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Study Completion Date:||February 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
IBD research group in KASID
KASID is Korean Association Study of Intestinal Disease. It has several research group suh as inflammatory bowel disease (IBD) research group.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01058356
|Korea, Republic of|
|KASID IBD Research Group|
|Seoul, Korea, Republic of, 135-280|
|Principal Investigator:||Sung-Ae Jung, MD, PhD||Ewha Womans University Mokdong Hospital|