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

This study has been completed.
Sponsor:
Information provided by:
Pharmbio Korea Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01058356
First received: January 26, 2010
Last updated: April 15, 2010
Last verified: April 2010
  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
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

Resource links provided by NLM:


Further study details as provided by Pharmbio Korea Co., Ltd.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01058356

Locations
Korea, Republic of
KASID IBD Research Group
Seoul, Korea, Republic of, 135-280
Sponsors and Collaborators
Pharmbio Korea Co., Ltd.
Investigators
Principal Investigator: Sung-Ae Jung, MD, PhD Ewha Womans University Mokdong Hospital
  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:
Infection
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
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on September 18, 2014