An observational study in Antibiotics Associated Colitis and Pulmonary Infection, sponsored by Pharmbio Korea Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-04-20.
Sponsored by Pharmbio Korea Co., Ltd. · Observational
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.
43 studies on the registry are indexed under Enterocolitis, Pseudomembranous; 5 are open to participants now.
Browse Enterocolitis, Pseudomembranous studies →Pharmbio Korea Co., Ltd. is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with respiratory tract infection who begin receiving antibiotic therapy (both hospitalized patients and out-patients)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
KASID is Korean Association Study of Intestinal Disease. It has several research group suh as inflammatory bowel disease (IBD) research group.
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
Presence of Bowel Habit Change (Watery Stools More Than 2 Times Per Day for at Least 2 Days)
Time frame: Up to14 days
From September 2008 to November 2009, medical clinic
| Milestone | Lacidofil Capsule Versus Placebo Drug |
|---|---|
| Started | 214 |
| Completed | 172 |
| Not completed | 42 |
| Withdrew: Adverse event | 5 |
| Withdrew: Administration of contraindicated drugs | 12 |
| Withdrew: Withdrawal by subject | 21 |
| Withdrew: Lost to follow-up | 4 |
AAD defined as: Watery stools more than 3 times per day for at least 2 days.
| participants | Lacidofil Capsule Versus Placebo Drug |
|---|---|
| Presence of AAD | 12 |
| participants | Lacidofil Capsule Versus Placebo Drug |
|---|---|
| Presence of Bowel Habit Change (Watery Stools More Than 2 Times Per Day for at Least 2 Days) | 25 |
Non-serious events are listed at a 2.3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lacidofil Capsule Versus Placebo Drug | — | 0/214 (0%) | 0/214 (0%) |
| Age, Categorical(Participants) | Lacidofil Capsule Versus Placebo Drug |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 112 |
| >=65 years | 102 |
| Age Continuous(years) | Lacidofil Capsule Versus Placebo Drug |
|---|---|
| Mean | 60.5 ± 15.5 |
| Sex: Female, Male(Participants) | Lacidofil Capsule Versus Placebo Drug |
|---|---|
| Female | 82 |
| Male | 132 |
| Region of Enrollment(participants) | Lacidofil Capsule Versus Placebo Drug |
|---|---|
| Korea, Republic of | 214 |
The record gives a start of Jan 2009, a primary completion of Jan 2010 and a completion of Feb 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2010, 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Enterocolitis, Pseudomembranous →
Pharmbio Korea Co., Ltd.