Effect of Probiotic Lactobacilli (Lacidofil Cap®) for the Prevention of Antibiotic-Associated Diarrhea
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Purpose
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.
| Condition |
|---|
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Antibiotics Associated Colitis Pulmonary Infection |
| Study Type: | Observational |
| 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 ]
| Enrollment: | 214 |
| Study Start Date: | January 2009 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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.
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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients with respiratory tract infection who begin receiving antibiotic therapy (both hospitalized patients and out-patients)
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.
Contacts and Locations| Korea, Republic of | |
| KASID IBD Research Group | |
| Seoul, Korea, Republic of, 135-280 | |
| Principal Investigator: | Sung-Ae Jung, MD, PhD | Ewha Womans University |
More Information
No publications provided
| Responsible Party: | NAM, Bong kil/ CEO & President, Pharmbio Korea |
| ClinicalTrials.gov Identifier: | NCT01058356 History of Changes |
| Other Study ID Numbers: | KASID_lacidofil_1 |
| Study First Received: | January 26, 2010 |
| Results First Received: | March 8, 2010 |
| Last Updated: | April 15, 2010 |
| Health Authority: | Korea: Institutional Review Board |
Keywords provided by Pharmbio Korea Co., Ltd.:
|
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 |
Additional relevant MeSH terms:
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Colitis Diarrhea Enterocolitis, Pseudomembranous Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Intestinal Diseases Signs and Symptoms, Digestive |
Signs and Symptoms Clostridium Infections Gram-Positive Bacterial Infections Bacterial Infections Enterocolitis Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013