DiarrheaPhase 3NCT01968408
Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children
A Phase 3 study testing Lactobacillus reuteri DSM 17938 in people with Diarrhea, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
AIM: To determine the efficacy of Lactobacillus reuteri DSM 17938 at a dose of 10(9) CFU for the prevention of nosocomial diarrhea. TRIAL DESIGN: Double-blind, placebo controlled RCT. INTERVENTION: L reuteri DSM 17938 in a daily dose of 10(9) CFU. Read more about this study
- Who is it for?
- Ages 1 month to 48 months
- Conditions the study is for
- Diarrhea
- What is being tested?
- Lactobacillus reuteri DSM 17938
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2012to Feb 2015
- Phase
- Phase 3
- 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 1 month to 48 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 1-48 mo admitted to the hospital for reasons other than diarrhea
- Signed informed consent.
Who cannot join
- Acute gastroenteritis within 3 days before admission
- Symptoms other than diarrhea suggesting gastroenteritis
- Use of probiotics within 7 days before admission
- Immunodeficiency disorders
- Breastfeeding >50%
- Underlying gastrointestinal tract disorder
- Malnutrition (weight/high <3pc)
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Pediatrics, Medical University of Warsaw
Warsaw, 01-410
About this study
Official title: Effectiveness of Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children: a Randomized, Double-blind Placebo Controlled Trial
AIM: To determine the efficacy of Lactobacillus reuteri DSM 17938 at a dose of 10(9) CFU for the prevention of nosocomial diarrhea.
TRIAL DESIGN: Double-blind, placebo controlled RCT. INTERVENTION: L reuteri DSM 17938 in a daily dose of 10(9) CFU. PRIMARY OUTCOME: Nosocomial diarrhoea (3 or more loose or watery stools in a 24 h that will occur more than 72 h after admission).
Read the detailed description
Nosocomial diarrhea is a common problem in hospitalized children. Previously, it has been documented that the administration of L reuteri DSM 17938 at a dose of 10(8) colony forming units (CFU) compared with placebo had no effect on the overall incidence of nosocomial diarrhea (Wanke \& Szajewska, J Pediatr 2012). Whether higher doses of L reuteri DSM 17938 have such effects needs to be substantiated in further randomized trials.
- Conditions
- Diarrhea
- Being tested
- Lactobacillus reuteri DSM 17938, Placebo
- Keywords
- nosocomial diarrhea, Lactobacillus reuteri DSM 17938, rotavirus diarrhea, probiotics
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus reuteri DSM 17938Dietary supplement
10(9) CFU/daily
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| L. reuteri DSM 17938 | Active comparator | Lactobacillus reuteri DSM 17938,10(9)CFU/daily (for the duration of hospitalization)
ARM I: Rotavirus vaccinated patients
ARM II: Non-rotavirus vaccinated patients Receives: Dietary Supplement: Lactobacillus reuteri DSM 17938 |
| Placebo | Placebo comparator | Placebo consists of an identical formulation in all respects except that the live probiotic bacteria were excluded
for the duration of hospitalization Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of nosocomial diarrhea (defined as the passage of 3 or more loose or watery stools in a 24-hour period that will occur more than 72 hours after admission)
Measured: Any time starting 72 h after admission
Secondary outcomes (8)
Incidence of diarrhea- passage of 3 or more loose or watery stools in a 24-h period
Measured: from the time of admission to the time of discharge of the hospital-expected average 3-5 days
Duration of diarrhea (ie, time till the last loose or watery stool from the onset of diarrhea)
Measured: during hospitalisation (expected average 3-5 days) and 72 h after discharge
Need and the length of intravenous rehydration due to diarrhea
Measured: During the hospitalization-expected average 3-5 days
Prolongation of the hospitalization due to nosocomial diarrhea
Measured: during the hospitalization-expected average 3-5 days
Incidence of rotavirus diarrhea (ie, detection of rotavirus or antigen in the stools)
Positive test for rotavirus or antigen in the stool sample
Measured: 72 hours after admission to the hospital to 72 hours after discharge
Incidence of chronic diarrhea- lasting more than 14 days
Measured: untill 14 days after onset of diarrhea
Length of hospital stay
Measured: During hospitalisation-expected average 3-5 days
Adverse effects
Measured: During hospitalisation (expected average 3-5 days) plus 72 h after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
- Study startSep 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanna Szajewska, Medical University of Warsaw
- Investigators
- Hanna Szajewska, MD, Profesor, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968408
- Sponsor's protocol ID
- KB/125/2012
- Status last verified
- Jun 2015
- First submitted
- 3 Sep 2012
- Last updated
- 18 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children: a Randomized, Double-blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT01968408
- Acronym / sponsor ID
- KB/125/2012
- Conditions
- Diarrhea
- Keywords
- nosocomial diarrhea, Lactobacillus reuteri DSM 17938, rotavirus diarrhea, probiotics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 24 Oct 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.
AIM: To determine the efficacy of Lactobacillus reuteri DSM 17938 at a dose of 10(9) CFU for the prevention of nosocomial diarrhea.
TRIAL DESIGN: Double-blind, placebo controlled RCT. INTERVENTION: L reuteri DSM 17938 in a daily dose of 10(9) CFU. PRIMARY OUTCOME: Nosocomial diarrhoea (3 or more loose or watery stools in a 24 h that will occur more than 72 h after admission).
Detailed description
Nosocomial diarrhea is a common problem in hospitalized children. Previously, it has been documented that the administration of L reuteri DSM 17938 at a dose of 10(8) colony forming units (CFU) compared with placebo had no effect on the overall incidence of nosocomial diarrhea (Wanke \& Szajewska, J Pediatr 2012). Whether higher doses of L reuteri DSM 17938 have such effects needs to be substantiated in further randomized trials.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L. reuteri DSM 17938 | Active comparator | Dietary Supplement: Lactobacillus reuteri DSM 17938Lactobacillus reuteri DSM 17938,10(9)CFU/daily (for the duration of hospitalization) ARM I: Rotavirus vaccinated patients ARM II: Non-rotavirus vaccinated patients |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo consists of an identical formulation in all respects except that the live probiotic bacteria were excluded for the duration of hospitalization |
Who may qualify
- Ages
- 1 month to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 1-48 mo admitted to the hospital for reasons other than diarrhea
- Signed informed consent.
Key exclusion criteria (7 listed)
- Acute gastroenteritis within 3 days before admission
- Symptoms other than diarrhea suggesting gastroenteritis
- Use of probiotics within 7 days before admission
- Immunodeficiency disorders
- Breastfeeding >50%
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 reuteri DSM 1793810(9) CFU/daily | Dietary supplement | L. reuteri DSM 17938 |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Incidence of nosocomial diarrhea (defined as the passage of 3 or more loose or watery stools in a 24-hour period that will occur more than 72 hours after admission)
Time frame: Any time starting 72 h after admission
8 secondary outcomes
Incidence of diarrhea- passage of 3 or more loose or watery stools in a 24-h period
Time frame: from the time of admission to the time of discharge of the hospital-expected average 3-5 days
Duration of diarrhea (ie, time till the last loose or watery stool from the onset of diarrhea)
Time frame: during hospitalisation (expected average 3-5 days) and 72 h after discharge
Need and the length of intravenous rehydration due to diarrhea
Time frame: During the hospitalization-expected average 3-5 days
Prolongation of the hospitalization due to nosocomial diarrhea
Time frame: during the hospitalization-expected average 3-5 days
Incidence of rotavirus diarrhea (ie, detection of rotavirus or antigen in the stools)
Time frame: 72 hours after admission to the hospital to 72 hours after discharge
Incidence of chronic diarrhea- lasting more than 14 days
Time frame: untill 14 days after onset of diarrhea
Length of hospital stay
Time frame: During hospitalisation-expected average 3-5 days
Adverse effects
Time frame: During hospitalisation (expected average 3-5 days) plus 72 h after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2015.
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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.
Hanna Szajewska, MD, Profesor principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lactobacillus reuteri DSM 17938 in people with Diarrhea, run by Medical University of Warsaw at 1 site in Poland.
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 7 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 18 Jun 2015. 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 Poland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of nosocomial diarrhea (defined as the passage of 3 or more loose or watery stools in a 24-hour period that will occur more than 72 hours after admission) (time frame: Any time starting 72 h after admission). 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 18 Jun 2015.