Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Presence of AAD | AAD defined as: Watery stools more than 3 times per day for at least 2 days. | Up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Bowel Habit Change (Watery Stools More Than 2 Times Per Day for at Least 2 Days) | Up to14 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with respiratory tract infection who begin receiving antibiotic therapy (both hospitalized patients and out-patients)
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sung-Ae Jung, MD, PhD | Ewha Womans University Mokdong Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KASID IBD Research Group | Seoul | 135-280 | South Korea |
Patients who begin receiving antibiotics prior to 48 hours before enrollment in this study
From September 2008 to November 2009, medical clinic
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lacidofil Capsule Versus Placebo Drug | Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lacidofil Capsule Versus Placebo Drug | Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Presence of AAD | AAD defined as: Watery stools more than 3 times per day for at least 2 days. | Posted | Number | participants | Up to 14 days |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lacidofil Capsule Versus Placebo Drug | Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Korea Association for the Study of Intestinal Disease (KASID) | Pharmbio Korea Co., Ltd. | 82-2-587-2551 | pharmbio@hotmail.com |
Not provided
| ID | Term |
|---|---|
| D004761 | Enterocolitis, Pseudomembranous |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
Not provided
Not provided
Not provided
| Lost to Follow-up |
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Presence of Bowel Habit Change (Watery Stools More Than 2 Times Per Day for at Least 2 Days) | Posted | Number | participants | Up to14 days |
|
|
|
|
| 0 |
| 214 |
| 0 |
| 214 |
Not provided
Not provided
| D007239 | Infections |
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |