Nosocomial InfectionPhase 3PNDNCT01046656
L Reuteri for the Prevention of Nosocomial Diarrhea
A Phase 3 study testing Lactobacillus reuteri (DSM 17938) in people with Nosocomial Infection and Diarrhea, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Nosocomial diarrhea is any diarrhea that a patient contracts in a health-care institution. In children, it is commonly caused by enteric pathogens, especially rotavirus. The reported incidence ranges from 4.5 to 22.6 episodes per 100 admissions. Read more about this study
- Who is it for?
- Ages 1 month to 48 months
- Conditions the study is for
- Nosocomial Infection, Diarrhea, Gastroenteritis
- What is being tested?
- Lactobacillus reuteri (DSM 17938)
- How many people
- 106 participants
- Where
- 1 sitePoland
- Study dates
- Dec 2009to Jul 2011
- 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
- age 1-48 mo
- cause of hospitalization must be other than acute gastroenteritis or diarrhea
Who cannot join
- acute gastroenteritis within 3 days before admission
- other symptoms which suggest gastroenteritis
- usage of probiotics and/or prebiotics within 7 days before admission
- visible blood in the stool
- patient in bad condition
- lack of approval from patients parents
- breastfeeding
- no compliance
Trial locations and contacts
1 site in 1 country.
Poland1 site
The Medical University of Warsaw, Department of Paediatrics
Warsaw, 01-184
About this study
Official title: Efficacy of Lactobacillus Reuteri DSM 17938 in the Prevention of Nosocomial Diarrhea in Children. Randomized Double-blind Placebo Controlled Trial
Nosocomial diarrhea is any diarrhea that a patient contracts in a health-care institution. In children, it is commonly caused by enteric pathogens, especially rotavirus. The reported incidence ranges from 4.5 to 22.6 episodes per 100 admissions. Nosocomial diarrhea may prolong the hospital stay and increase medical costs. One of the potential strategies for the prevention of nosocomial infections is the use of probiotics. The number of studies have shown the efficacy of Lactobacillus reuteri (DSM 17938) in the treatment of acute diarrhea. However, there are no data on the efficacy of L. reuteri in the prevention of nosocomial diarrhea. The investigators, therefore, plan to perform the study with the aim of evaluating the role of Lactobacillus reuteri DSM 17938 administration in the prevention of nosocomial gastroenteritis in a pediatric hospital setting.
Read the detailed description
Infants will be randomly assigned at admission to receive L. reuteri in dose of 10(8) CFU in 5 drops of oil suspension or a comparable placebo once daily for the entire duration of their hospital stay.
Patients will be evaluated daily for stool number and consistency. In case of loose or watery stools occurring within 3 days after discharge, patients will be advised to contact hospital physicians. Stool samples obtained weekly and during an episode of diarrhea, will be analyzed for bacteria with standard stool cultures and rotavirus and adenovirus antigen.
- Conditions
- Nosocomial Infection, Diarrhea, Gastroenteritis
- Being tested
- Lactobacillus reuteri (DSM 17938)
- Keywords
- nosocomial infection, diarrhea, Lactobacillus reuteri, gastroenteritis, rotavirus
- Medical subject headings
- Cross Infection, Diarrhea, Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus reuteri (DSM 17938)Dietary supplement
5 drops once daily (10(8) CFU) for the entire duration of hospital stay
What is being measured
The primary outcome is the main question the study is designed to answer.
Nosocomial diarrhea (passage of 3 or more loose or watery stools in a 24-hour period that will occur more than 72 hours after admission)
Measured: from 72nd hrs till the and of hospitalization no longer than 14 days
Secondary outcomes (7)
Length of hospital stay in days
Measured: from 72nd hrs till the and of hospitalization no longer than 14 days
Recurrent diarrhea - recurrence of diarrhea after 48h of normal stools
Measured: from 72nd hrs till the and of hospitalization no longer than 14 days
Chronic diarrhea - diarrhea beyond 14 days
Measured: from 72nd hrs till the and of hospitalization no longer than 14 days
Diarrhea - the passage of 3 or more loose of watery stools in a 24 h period
Measured: from 72nd hrs till the and of hospitalization no longer than 14 days
Rotavirus infection - detection of rotavirus or antigen in the stools
Measured: from 72nd hrs till the and of hospitalization no longer than 14 days
Duration of diarrhea - time till the last loose watery stools from the onset of diarrhea measured in days)
Measured: from 72nd hrs till the and of hospitalization no longer than 14 days
Need for rehydration
Measured: from 72nd hrs till the and of hospitalization no longer than 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionJun 2011
- Study completionJul 2011
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 Nosocomial InfectionStudies 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
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046656
- Sponsor's protocol ID
- 152/2009
- Other IDs
- 152/2009
- Acronym
- PND
- Status last verified
- Dec 2009
- First submitted
- 16 Dec 2009
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wanke M, Szajewska H. Lack of an effect of Lactobacillus reuteri DSM 17938 in preventing nosocomial diarrhea in children: a randomized, double-blind, placebo-controlled trial. J Pediatr. 2012 Jul;161(1):40-3.e1. doi: 10.1016/j.jpeds.2011.12.049. Epub 2012 Feb 4.
PubMed 22306046
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lactobacillus Reuteri DSM 17938 in the Prevention of Nosocomial Diarrhea in Children. Randomized Double-blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT01046656
- Acronym / sponsor ID
- PND / 152/2009
- Conditions
- Nosocomial Infection, Diarrhea, Gastroenteritis
- Keywords
- nosocomial infection, diarrhea, Lactobacillus reuteri, gastroenteritis, rotavirus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 12 Jan 2010 (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.
Nosocomial diarrhea is any diarrhea that a patient contracts in a health-care institution. In children, it is commonly caused by enteric pathogens, especially rotavirus. The reported incidence ranges from 4.5 to 22.6 episodes per 100 admissions. Nosocomial diarrhea may prolong the hospital stay and increase medical costs. One of the potential strategies for the prevention of nosocomial infections is the use of probiotics. The number of studies have shown the efficacy of Lactobacillus reuteri (DSM 17938) in the treatment of acute diarrhea. However, there are no data on the efficacy of L. reuteri in the prevention of nosocomial diarrhea. The investigators, therefore, plan to perform the study with the aim of evaluating the role of Lactobacillus reuteri DSM 17938 administration in the prevention of nosocomial gastroenteritis in a pediatric hospital setting.
Detailed description
Infants will be randomly assigned at admission to receive L. reuteri in dose of 10(8) CFU in 5 drops of oil suspension or a comparable placebo once daily for the entire duration of their hospital stay.
Patients will be evaluated daily for stool number and consistency. In case of loose or watery stools occurring within 3 days after discharge, patients will be advised to contact hospital physicians. Stool samples obtained weekly and during an episode of diarrhea, will be analyzed for bacteria with standard stool cultures and rotavirus and adenovirus antigen.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 1 month to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- age 1-48 mo
- cause of hospitalization must be other than acute gastroenteritis or diarrhea
Key exclusion criteria (8 listed)
- acute gastroenteritis within 3 days before admission
- other symptoms which suggest gastroenteritis
- usage of probiotics and/or prebiotics within 7 days before admission
- visible blood in the stool
- patient in bad condition
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 17938)5 drops once daily (10(8) CFU) for the entire duration of hospital stay | Dietary supplement | – |
Primary outcome
Nosocomial diarrhea (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: from 72nd hrs till the and of hospitalization no longer than 14 days
7 secondary outcomes
Length of hospital stay in days
Time frame: from 72nd hrs till the and of hospitalization no longer than 14 days
Recurrent diarrhea - recurrence of diarrhea after 48h of normal stools
Time frame: from 72nd hrs till the and of hospitalization no longer than 14 days
Chronic diarrhea - diarrhea beyond 14 days
Time frame: from 72nd hrs till the and of hospitalization no longer than 14 days
Diarrhea - the passage of 3 or more loose of watery stools in a 24 h period
Time frame: from 72nd hrs till the and of hospitalization no longer than 14 days
Rotavirus infection - detection of rotavirus or antigen in the stools
Time frame: from 72nd hrs till the and of hospitalization no longer than 14 days
Duration of diarrhea - time till the last loose watery stools from the onset of diarrhea measured in days)
Time frame: from 72nd hrs till the and of hospitalization no longer than 14 days
Need for rehydration
Time frame: from 72nd hrs till the and of hospitalization no longer than 14 days
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 31 Jan 2012.
- Derived from this study: PubMed 22306046Wanke M, Szajewska H. Lack of an effect of Lactobacillus reuteri DSM 17938 in preventing nosocomial diarrhea in children: a randomized, double-blind, placebo-controlled trial. J Pediatr. 2012 Jul;161(1):40-3.e1. doi: 10.1016/j.jpeds.2011.12.049. Epub 2012 Feb 4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Nosocomial Infection and 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 8 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 31 Jan 2012. 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. 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?
Nosocomial diarrhea (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: from 72nd hrs till the and of hospitalization no longer than 14 days). 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 NCT01046656, 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 31 Jan 2012.