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

NCT01058356 | Completed Results DMC

• 1 other identifier: KASID_lacidofil_1
• Study Type: observational
• Target: 214
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Presence of AAD

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

  Up to 14 days

Secondary Outcomes (1)

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

  Up to14 days

Study Arms (1)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with respiratory tract infection who begin receiving antibiotic therapy (both hospitalized patients and out-patients)

You may qualify if:

• Male or female over 18
• Patients with respiratory tract infection who are receiving an oral or injection antibiotics.
• Patients who begin receiving antibiotics within 48 hours before enrollment in this study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pharmbio Korea Co., Ltd.: lead

Study Sites (1)

KASID IBD Research Group

Seoul, 135-280, South Korea

Location

MeSH Terms

Conditions

Enterocolitis, Pseudomembranous

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Korea Association for the Study of Intestinal Disease (KASID)
• Organization: Pharmbio Korea Co., Ltd.

pharmbio@hotmail.com

82-2-587-2551

Study Officials

• Sung-Ae Jung, MD, PhD

  Ewha Womans University Mokdong Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 26, 2010
• First Posted: January 28, 2010
• Study Start: January 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: February 1, 2010
• Last Updated: April 20, 2010
• Results First Posted: March 31, 2010

Record last verified: 2010-04

Locations

KR (1)