DiarrheaPhase 4NCT01792739
Lactobacillus Preparation on the Incidence of Diarrhea
A Phase 4 study testing Lactobacillus casei variety rhamnosus granules in people with Diarrhea and Death, run by Seoul National University Hospital at 3 sites in South Korea.
Trial summary
The purpose of this trial is to clarify the impact of lactobacillus preparation on the incidence of diarrhea in ICU-admitted patients. Almost all patients in ICU are treated with antibiotics for the effective control of various infections. However, antibiotics-associated diarrhea is another matter of concern. Read more about this study
- Who is it for?
- Ages 20 years and older
- What is being tested?
- Lactobacillus casei variety rhamnosus granules
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Nov 2010to Oct 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients admitted in intensive care unit
- Age more than 19
Who cannot join
- Diarrhea occurence within 1 week of ICU admission
- Recent history of probiotics use (within 1 month)
- GI obstruction
- History of abnormal symptoms and sign for the probiotics use (rash, edema, sepsis, etc.)
- immunocompromized patients
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites, 3 recruiting
- Recruiting
Myongji Hospital
Goyang, Deokyang-gu, 412-270
Joo-Won Min, M.S, 82-31-810-5423, kmfindie@hanmail.net
- Recruiting
Seoul National University Bundang Hospital
Seongnam, Bundang-Gu, 463-707
Jong Sun Park, M.S, 82 10 3297 4632, jspark.im@gmail.com
- Recruiting
SMG-SNU Boramae Medical Center
Seoul, Dongjak-gu, 156-707
Chang Hoon Lee, Doctor, 82-10-9563-2310, kauri670@gmail.com
About this study
Official title: The Impact of Lactobacillus Preparation on the Incidence of Diarrhea in Intensive Care Unit-admitted Patients : Randomized Controlled Trial
The purpose of this trial is to clarify the impact of lactobacillus preparation on the incidence of diarrhea in ICU-admitted patients.
Almost all patients in ICU are treated with antibiotics for the effective control of various infections. However, antibiotics-associated diarrhea is another matter of concern. Many previous studies were proved that the use of probiotic lactobacillus preparation can reduce antibiotics-associated diarrhea in ward-admitted patients. In this study, we are planning to perform a similar study in severely ill patients in ICU.
- Being tested
- Lactobacillus casei variety rhamnosus granules, Placebo
- Keywords
- Probiotics, Diarrhea, Intentive care units
- Medical subject headings
- Diarrhea, Death, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus casei variety rhamnosus granulesDrug
Also called RAMNOS GRANULS
Lactobacillus casei variety rhamnosus granules
: 3 gram per day (1g-1g-1g, 3 times per day)
PlaceboDrug
Placebo granules
: 3 gram per day (1g-1g-1g, 3 times per day)
| Study group | Role | What they receive |
|---|---|---|
| Kadit B | Experimental | Probiotic Lactobacillus casei variety rhamnosus granules Receives: Drug: Lactobacillus casei variety rhamnosus granules |
| Kadit A | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diarrhea-free days
If patients admit to ICU, the patient can be registered to probiotics or placebo arm. After the registration, probiotics would be administered to the patients. If loose stool >600ml/day occurs during ICU residence, we can determine that occurence of diarrhea.
"Diarrhea-free days" mean the duration from the day of 1st administration of probiotics till the day of 1st diarrhea.
If patients are transferred to ward, this study ends in each patient.
Measured: Duration from the first-administration day of probiotics till the first onset day of diarrhea during ICU residence (up to 8 weeks)
Secondary outcomes (3)
28day-mortality
Mortality in 28th day of ICU residence
Measured: 28 day
Positive results of C.difficile toxin
If diarrhea (>600ml/day) occurs during ICU residence, we will perform C.difficile toxin assays to determine the cause of diarrhea.
Measured: The first onset of diarrhea during ICU residence (up to 8 weeks)
ICU-acquired pneumonia
Definition of ICU-acquired pneumonia
- Newly developed pneumonia during ICU residence
- Aggravation of pneumonia during ICU residence
Measured: The first day of occurence of ICU-acquired pneumonia (up to 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startNov 2010
- Primary completionSep 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Hoon Lee, Seoul National University Hospital
- Investigators
- Chang Hoon Lee, Doctor, Principal investigator, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792739
- Sponsor's protocol ID
- ICU_probiotics
- Status last verified
- Feb 2013
- First submitted
- 9 Feb 2012
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Hickson M, D'Souza AL, Muthu N, Rogers TR, Want S, Rajkumar C, Bulpitt CJ. Use of probiotic Lactobacillus preparation to prevent diarrhoea associated with antibiotics: randomised double blind placebo controlled trial. BMJ. 2007 Jul 14;335(7610):80. doi: 10.1136/bmj.39231.599815.55. Epub 2007 Jun 29.
PubMed 17604300
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Lactobacillus Preparation on the Incidence of Diarrhea in Intensive Care Unit-admitted Patients : Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01792739
- Acronym / sponsor ID
- ICU_probiotics
- Keywords
- Probiotics, Diarrhea, Intentive care units
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 15 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to clarify the impact of lactobacillus preparation on the incidence of diarrhea in ICU-admitted patients.
Almost all patients in ICU are treated with antibiotics for the effective control of various infections. However, antibiotics-associated diarrhea is another matter of concern. Many previous studies were proved that the use of probiotic lactobacillus preparation can reduce antibiotics-associated diarrhea in ward-admitted patients. In this study, we are planning to perform a similar study in severely ill patients in ICU.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kadit B | Experimental | Drug: Lactobacillus casei variety rhamnosus granulesProbiotic Lactobacillus casei variety rhamnosus granules |
| Kadit A | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients admitted in intensive care unit
- Age more than 19
Key exclusion criteria (5 listed)
- Diarrhea occurence within 1 week of ICU admission
- Recent history of probiotics use (within 1 month)
- GI obstruction
- History of abnormal symptoms and sign for the probiotics use (rash, edema, sepsis, etc.)
- immunocompromized patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus casei variety rhamnosus granulesAlso: RAMNOS GRANULSLactobacillus casei variety rhamnosus granules : 3 gram per day (1g-1g-1g, 3 times per day) | Drug | Kadit B |
| PlaceboPlacebo granules : 3 gram per day (1g-1g-1g, 3 times per day) | Drug | Kadit A |
Primary outcome
Diarrhea-free days
Time frame: Duration from the first-administration day of probiotics till the first onset day of diarrhea during ICU residence (up to 8 weeks)
If patients admit to ICU, the patient can be registered to probiotics or placebo arm. After the registration, probiotics would be administered to the patients. If loose stool >600ml/day occurs during ICU residence, we can determine that occurence of diarrhea. "Diarrhea-free days" mean the duration from the day of 1st administration of probiotics till the day of 1st diarrhea. If patients are transferred to ward, this study ends in each patient.
3 secondary outcomes
28day-mortality
Time frame: 28 day
Positive results of C.difficile toxin
Time frame: The first onset of diarrhea during ICU residence (up to 8 weeks)
ICU-acquired pneumonia
Time frame: The first day of occurence of ICU-acquired pneumonia (up to 8 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
- Results publication: PubMed 17604300Hickson M, D'Souza AL, Muthu N, Rogers TR, Want S, Rajkumar C, Bulpitt CJ. Use of probiotic Lactobacillus preparation to prevent diarrhoea associated with antibiotics: randomised double blind placebo controlled trial. BMJ. 2007 Jul 14;335(7610):80. doi: 10.1136/bmj.39231.599815.55. Epub 2007 Jun 29.
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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.
Chang Hoon Lee, Doctor principal investigator
Seoul National University College of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lactobacillus casei variety rhamnosus granules in people with Diarrhea and Death, run by Seoul National University Hospital at 3 sites 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chang-Hoon Lee, Doctor (82 10 9563 2310, kauri670@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diarrhea-free days (time frame: Duration from the first-administration day of probiotics till the first onset day of diarrhea during ICU residence (up to 8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01792739, which also lists 1 linked publication.
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 15 Feb 2013.