Clinical trial NCT01058356: Effect of Probiotic Lactobacilli (Lacidofil Cap®) for the Prevention of Antibiotic-Associated Diarrhea
Official title: Effect of Probiotic Lactobacilli (Lacidofil Cap®) for the Prevention of Antibiotic-Associated Diarrhea: Prospective, Randomized Double-blind, Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antibiotics Associated Colitis
Pulmonary Infection
Keywords: antibiotics associated colitis
lactobacilli
probiotics
prevention
pulmonary infection
Prevention of antibiotics associated colitis
the role of probiotics for prevention of antibiotics associated colitis
the lactobacilli effect for antibiotics associated colitis
antibiotic associated colitis on pulmonary infectious disease
Lead sponsor: Pharmbio Korea Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-01-28
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with respiratory tract infection who begin receiving antibiotic therapy (both hospitalized patients and out-patients)

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Presence of AAD
timeFrame: Up to 14 days
Secondary outcomes:
measure: Presence of Bowel Habit Change (Watery Stools More Than 2 Times Per Day for at Least 2 Days)
timeFrame: Up to14 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: KASID IBD Research Group
Study officials:
affiliation: Ewha Womans University Mokdong Hospital
name: Sung-Ae Jung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: