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.

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Key information

Conditions

Antibiotics Associated Colitis Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Digestive System Diseases Enterocolitis Enterocolitis, Pseudomembranous Gastroenteritis Gastrointestinal Diseases Gram-Positive Bacterial Infections Infections Intestinal Diseases Pulmonary Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

KASID IBD Research Group

Seoul, 135-280, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male or female over 18
Patients with respiratory tract infection who are receiving an oral or injection antibiotics.
Signed informed consent form prior to inclusion in the study.
Patients who begin receiving antibiotics within 48 hours before enrollment in this study.

Exclusion criteria

Diagnosed Clostridium difficile colitis within the last 3 months
Patients with tube feeding, ileostomy or colostomy
Patients with basal diarrheal disease; acute enteritis, chronic diarrhea such as inflammatory bowel disease (IBD) etc, radiation enteritis, ischemic colitis and diarrhea caused by carcinoids etc.
Patients receiving other probiotics during the last 15 days
Patients treated with immunosuppressant drugs or immune deficiency patients
Patients with radiotherapy and chemotherapy treatment for cancer.
Patients treated with antidiarrheal, antispasmodic or motility agents for other diseases.
Pregnant/Lactating women
Patients with gastrointestinal (GI) surgery during the last 3 months.
A history of hypersensitivity to cephalosporins, penicillin or clavulanic acid.
Patients with verified diabetic autonomic neuropathy.
Patients with organ transplants.
Patients with underlying conditions or diseases which, in the opinion of the investigator, are unsuitable for inclusion.

Treatment and study plan

Primary outcomes

Presence of AAD

Time frame: Up to 14 days

AAD defined as: Watery stools more than 3 times per day for at least 2 days.

Secondary outcomes

Presence of Bowel Habit Change (Watery Stools More Than 2 Times Per Day for at Least 2 Days)

Time frame: Up to14 days

Sponsors and collaborators

Lead sponsor

Pharmbio Korea Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Jan 28, 2010
Registry last updated: Apr 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed