Antibiotics Associated ColitisNCT01058356
Effect of Probiotic Lactobacilli (Lacidofil Cap®) for the Prevention of Antibiotic-Associated Diarrhea
An observational study of Antibiotics Associated Colitis and Pulmonary Infection, run by Pharmbio Korea Co., Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antibiotics Associated Colitis, Pulmonary Infection
- How many people
- 214 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2009to Feb 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with respiratory tract infection who begin receiving antibiotic therapy (both hospitalized patients and out-patients)
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Probiotic Lactobacilli (Lacidofil Cap®) for the Prevention of Antibiotic-Associated Diarrhea: Prospective, Randomized Double-blind, Multicenter Study
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.
- 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
- Medical subject headings
- Enterocolitis, Pseudomembranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of AAD
AAD defined as: Watery stools more than 3 times per day for at least 2 days.
Measured: 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)
Measured: Up to14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2010 (estimated)
- Study startJan 2009
- Primary completionJan 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Antibiotics Associated ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmbio Korea Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sung-Ae Jung, MD, PhD, Principal investigator, Ewha Womans University Mokdong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058356
- Sponsor's protocol ID
- KASID_lacidofil_1
- Status last verified
- Apr 2010
- First submitted
- 26 Jan 2010
- Last updated
- 20 Apr 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotic Lactobacilli (Lacidofil Cap®) for the Prevention of Antibiotic-Associated Diarrhea: Prospective, Randomized Double-blind, Multicenter Study
- ClinicalTrials.gov ID
- NCT01058356
- Acronym / sponsor ID
- KASID_lacidofil_1
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Pharmbio Korea Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 28 Jan 2010 (estimated)
- Results
- Posted 31 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with respiratory tract infection who begin receiving antibiotic therapy (both hospitalized patients and out-patients)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Presence of Bowel Habit Change (Watery Stools More Than 2 Times Per Day for at Least 2 Days)
Time frame: Up to14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung-Ae Jung, MD, PhD principal investigator
Ewha Womans University Mokdong Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antibiotics Associated Colitis and Pulmonary Infection, run by Pharmbio Korea Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of AAD (time frame: Up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2010.