Antibiotics Associated Colitis, Pulmonary Infection
Conditions
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
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.
Interventions
None listed
Sponsors
Pharmbio Korea Co., Ltd.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of AAD | Up to 14 days | AAD defined as: Watery stools more than 3 times per day for at least 2 days. |
Secondary
| Measure | Time frame |
|---|---|
| Presence of Bowel Habit Change (Watery Stools More Than 2 Times Per Day for at Least 2 Days) | Up to14 days |
Countries
South Korea
Participant flow
Recruitment details
From September 2008 to November 2009, medical clinic
Pre-assignment details
Patients who begin receiving antibiotics prior to 48 hours before enrollment in this study
Participants by arm
| Arm | Count |
|---|---|
| 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) | 214 |
| Total | 214 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administration of contraindicated drugs | 12 |
| Overall Study | Adverse Event | 5 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Withdrawal by Subject | 21 |
Baseline characteristics
| Characteristic | Lacidofil Capsule Versus Placebo Drug |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 102 Participants |
| Age, Categorical Between 18 and 65 years | 112 Participants |
| Age Continuous | 60.5 years STANDARD_DEVIATION 15.5 |
| Region of Enrollment Korea, Republic of | 214 participants |
| Sex: Female, Male Female | 82 Participants |
| Sex: Female, Male Male | 132 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 214 |
| serious Total, serious adverse events | 0 / 214 |
Outcome results
Primary
Presence of AAD
AAD defined as: Watery stools more than 3 times per day for at least 2 days.
Time frame: Up to 14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lacidofil Capsule Versus Placebo Drug | Presence of AAD | 12 participants |
Comparison: Null hypothesis: The efficay of the probiotic Lactobacilli (Lacidofil cap®) for the prevention of AAD in adults is not different form the placebo group in multi-center, randomized, placebo-controlled, double-blind trial.~Power calculation:~The assumption of sample size calculation:~difference 18% (8% : 26%) α: 0.05, statistical power: 90%, two sided difference: 18% Compliance: 80%~\- Unadjusted sample size (N=200) 180 + 10(%) drop out = 180 + 180/ (1-0.1)2 = 222.2 Total 220 subjectsp-value: <0.0595% CI: [0.17, 4.15]Regression, Logistic
Secondary
Presence of Bowel Habit Change (Watery Stools More Than 2 Times Per Day for at Least 2 Days)
Time frame: Up to14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lacidofil Capsule Versus Placebo Drug | Presence of Bowel Habit Change (Watery Stools More Than 2 Times Per Day for at Least 2 Days) | 25 participants |
Comparison: Null hypothesis: The efficay of the probiotic Lactobacilli (Lacidofil cap®) for the prevention of AAD in adults is not different form the placebo group in multi-center, randomized, placebo-controlled, double-blind trial.~Power calculation:~The assumption of sample size calculation:~difference 18% (8% : 26%) α: 0.05, statistical power: 90%, two sided difference: 18% Compliance: 80%~\- Unadjusted sample size (N=200) 180 + 10(%) drop out = 180 + 180/ (1-0.1)2 = 222.2 Total 220 subjectsp-value: <0.0595% CI: [0.18, 1.55]Regression, Logistic