Clinical Trial: Effect of Probiotic Lactobacilli (Lacidofil Cap®) for the Prevention of Antibiotic-Associated Diarrhea

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Effect of Probiotic Lactobacilli (Lacidofil Cap®) for the Prevention of Antibiotic-Associated Diarrhea: Prospective, Randomized Double-blind, Multicenter Study

Brief Summary: 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.

Detailed Summary:
Sponsor: Pharmbio Korea Co., Ltd.

Current Primary Outcome: Presence of AAD [ Time Frame: Up to 14 days ]

Original Primary Outcome: Presence of AAD [ Time Frame: within 14 days after starting the trial ]

Current Secondary Outcome: Presence of Bowel Habit Change (Watery Stools More Than 2 Times Per Day for at Least 2 Days) [ Time Frame: Up to14 days ]

Original Secondary Outcome: Presence of Bowel Habit Change (Watery Stools More Than 2 Times Per Day for at Least 2 Days) [ Time Frame: 14 days ]

Information By: Pharmbio Korea Co., Ltd.

Dates:
Date Received: January 26, 2010
Date Started: January 2009
Date Completion:
Last Updated: April 15, 2010
Last Verified: April 2010