Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01058356
Recruitment Status : Completed
First Posted : January 28, 2010
Results First Posted : March 31, 2010
Last Update Posted : April 20, 2010
Information provided by:
Pharmbio Korea Co., Ltd.

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.

Condition or disease
Antibiotics Associated Colitis Pulmonary Infection

Layout table for study information
Study Type : Observational
Actual Enrollment : 214 participants
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
Study Start Date : January 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Diarrhea

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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01058356

Layout table for location information
Korea, Republic of
KASID IBD Research Group
Seoul, Korea, Republic of, 135-280
Sponsors and Collaborators
Pharmbio Korea Co., Ltd.
Layout table for investigator information
Principal Investigator: Sung-Ae Jung, MD, PhD Ewha Womans University Mokdong Hospital

Layout table for additonal information
Responsible Party: NAM, Bong kil/ CEO & President, Pharmbio Korea Identifier: NCT01058356     History of Changes
Other Study ID Numbers: KASID_lacidofil_1
First Posted: January 28, 2010    Key Record Dates
Results First Posted: March 31, 2010
Last Update Posted: April 20, 2010
Last Verified: April 2010
Keywords provided by Pharmbio Korea Co., Ltd.:
antibiotics associated colitis
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:
Layout table for MeSH terms
Enterocolitis, Pseudomembranous
Anti-Infective Agents
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Antibiotics, Antitubercular
Antitubercular Agents