DiarrheaPhase 4NCT02871908
Lactobacillus Reuteri DSM 17938 in the Prevention of Antibiotic-associated Diarrhea in Children: Protocol of a Randomized Controlled Trial
A Phase 4 study testing Lactobacillus reuteri DSM 17938 in people with Diarrhea and Antibiotic Associated Diarrhea, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The aim of this study is to assess the effect of Lactobacillus reuteri DSM 17938 administration for the prevention of diarrhea and AAD in children. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Diarrhea, Antibiotic Associated Diarrhea
- What is being tested?
- Lactobacillus reuteri DSM 17938
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 sitePoland
- Study dates
- Dec 2016to Mar 2018
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age younger than 18 years;
- oral or intravenous antibiotic therapy which started within 24 hours of enrollment;
- signed informed consent.
Who cannot join
- pre-existing acute or chronic diarrhea,
- history of chronic gastrointestinal disease (e.g., inflammatory bowel disease, cystic fibrosis, celiac disease, food allergy) or other severe chronic disease (e.g., neoplastic diseases), immunodeficiency,
- use of probiotics within 2 weeks prior to enrollment,
- use of antibiotics within 4 weeks prior to enrollment,
- prematurity, and exclusive breastfeeding.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Paediatrics, The Medical University of Warsaw, Poland
Warsaw, 02-091
About this study
The aim of this study is to assess the effect of Lactobacillus reuteri DSM 17938 administration for the prevention of diarrhea and AAD in children.
Read the detailed description
Introduction:
Addition of some probiotics appears to reduce the risk of antibiotic-associated diarrhea (AAD). Effects of probiotics are strain specific, thus the efficacy and safety of each probiotic strain should be established separately. We aim to assess the effect of Lactobacillus reuteri DSM 17938 administration for the prevention of diarrhea and AAD in children.
Methods and analysis:
A total of 250 children younger than 18 years treated with antibiotics will be enrolled into a double-blind, randomized placebo-controlled trial in which they will additionally receive L reuteri DSM 17938 at a dose 2 x 10^8 colony-forming units or an identically appearing placebo, orally, twice daily, for the entire duration of antibiotic treatment. The primary outcome measures will be the frequency of diarrhea and AAD. Diarrhea will be defined according to one of 3 definitions: (a) ≥3 loose or watery stools per day for a minimum of 48 hours during antibiotic treatment; (b) ≥3 loose or watery stools per day for a minimum of 24 hours during antibiotic treatment; (c) ≥2 loose or watery stools per day for a minimum of 24 hours during antibiotic treatment. AAD will be diagnosed in cases of diarrhea, defined clinically as above, caused by C. difficile or for otherwise unexplained diarrhea (i.e. negative laboratory stool tests for infectious agents).
- Conditions
- Diarrhea, Antibiotic Associated Diarrhea
- Being tested
- Lactobacillus reuteri DSM 17938, Placebo
- 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 17938Drug
Lactobacillus reuteri DSM 17938 twice daily 2 x 10^8
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| L reuteri DSM 17938 | Experimental | L reuteri DSM 17938 2 x 10^8 twice daily Receives: Drug: Lactobacillus reuteri DSM 17938 |
| Controls | Placebo comparator | Identically appearing placebo twice daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequencies of diarrhea and antibiotic associated diarrhea
Three different definitions of diarrhea will be used, as the definitions of diarrhea/AAD in published studies vary. These will include diarrhea defined as: (a) ≥3 loose or watery stools per day for a minimum of 48 hours during antibiotic treatment; (b) ≥3 loose or watery stools per day for a minimum of 24 hours during antibiotic treatment, and (c) ≥2 loose or watery stools per day for a minimum of 24 hours during antibiotic treatment. AAD will be diagnosed in cases of diarrhea, defined clinically as above, caused by C. difficile or for otherwise unexplained diarrhea (i.e., negative laboratory stool tests for infectious agents). In all cases, loose or watery stools will correspond to scores of 5 to 7 on the BSF scale or A-consistency on the AISS.
Measured: during antibiotic treatment, an average of 10 days and 7 days of follow up
Secondary outcomes (5)
infectious diarrhea
rotavirus, adenovirus, norovirus, Salmonella, Shigella, Campylobacter, Yersinia and C. difficile
Measured: during antibiotic treatment, an average of 10 days and 7 days of follow up
the need for discontinuation of the antibiotic treatment
Measured: during antibiotic treatment, an average of 10 days
the need for hospitalization to manage the diarrhea (in outpatients)
Measured: during antibiotic treatment, an average of 10 days and 7 days of follow up
the need for intravenous rehydration in any of the study groups
Measured: during antibiotic treatment, an average of 10 days and 7 days of follow up
adverse events
Measured: during antibiotic treatment, an average of 10 days and 7 days of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study startDec 2016
- Primary completionMar 2018
- Study completionMar 2018
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 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871908
- Sponsor's protocol ID
- 12/08/2016
- Status last verified
- Mar 2018
- First submitted
- 16 Aug 2016
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Kolodziej M, Szajewska H. Lactobacillus reuteri DSM 17938 in the prevention of antibiotic-associated diarrhoea in children: protocol of a randomised controlled trial. BMJ Open. 2017 Jan 5;7(1):e013928. doi: 10.1136/bmjopen-2016-013928.
PubMed 28057659
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactobacillus Reuteri DSM 17938 in the Prevention of Antibiotic-associated Diarrhea in Children: Protocol of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02871908
- Acronym / sponsor ID
- 12/08/2016
- Conditions
- Diarrhea, Antibiotic Associated Diarrhea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 18 Aug 2016 (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 aim of this study is to assess the effect of Lactobacillus reuteri DSM 17938 administration for the prevention of diarrhea and AAD in children.
Detailed description
Introduction:
Addition of some probiotics appears to reduce the risk of antibiotic-associated diarrhea (AAD). Effects of probiotics are strain specific, thus the efficacy and safety of each probiotic strain should be established separately. We aim to assess the effect of Lactobacillus reuteri DSM 17938 administration for the prevention of diarrhea and AAD in children.
Methods and analysis:
A total of 250 children younger than 18 years treated with antibiotics will be enrolled into a double-blind, randomized placebo-controlled trial in which they will additionally receive L reuteri DSM 17938 at a dose 2 x 10^8 colony-forming units or an identically appearing placebo, orally, twice daily, for the entire duration of antibiotic treatment. The primary outcome measures will be the frequency of diarrhea and AAD. Diarrhea will be defined according to one of 3 definitions: (a) ≥3 loose or watery stools per day for a minimum of 48 hours during antibiotic treatment; (b) ≥3 loose or watery stools per day for a minimum of 24 hours during antibiotic treatment; (c) ≥2 loose or watery stools per day for a minimum of 24 hours during antibiotic treatment. AAD will be diagnosed in cases of diarrhea, defined clinically as above, caused by C. difficile or for otherwise unexplained diarrhea (i.e. negative laboratory stool tests for infectious agents).
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 | Experimental | Drug: Lactobacillus reuteri DSM 17938L reuteri DSM 17938 2 x 10^8 twice daily |
| Controls | Placebo comparator | Drug: PlaceboIdentically appearing placebo twice daily |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- age younger than 18 years;
- oral or intravenous antibiotic therapy which started within 24 hours of enrollment;
- signed informed consent.
Key exclusion criteria (5 listed)
- pre-existing acute or chronic diarrhea,
- history of chronic gastrointestinal disease (e.g., inflammatory bowel disease, cystic fibrosis, celiac disease, food allergy) or other severe chronic disease (e.g., neoplastic diseases), immunodeficiency,
- use of probiotics within 2 weeks prior to enrollment,
- use of antibiotics within 4 weeks prior to enrollment,
- prematurity, and exclusive breastfeeding.
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 17938Lactobacillus reuteri DSM 17938 twice daily 2 x 10^8 | Drug | L reuteri DSM 17938 |
| PlaceboPlacebo | Drug | Controls |
Primary outcome
frequencies of diarrhea and antibiotic associated diarrhea
Time frame: during antibiotic treatment, an average of 10 days and 7 days of follow up
Three different definitions of diarrhea will be used, as the definitions of diarrhea/AAD in published studies vary. These will include diarrhea defined as: (a) ≥3 loose or watery stools per day for a minimum of 48 hours during antibiotic treatment; (b) ≥3 loose or watery stools per day for a minimum of 24 hours during antibiotic treatment, and (c) ≥2 loose or watery stools per day for a minimum of 24 hours during antibiotic treatment. AAD will be diagnosed in cases of diarrhea, defined clinically as above, caused by C. difficile or for otherwise unexplained diarrhea (i.e., negative laboratory stool tests for infectious agents). In all cases, loose or watery stools will correspond to scores of 5 to 7 on the BSF scale or A-consistency on the AISS.
5 secondary outcomes
infectious diarrhea
Time frame: during antibiotic treatment, an average of 10 days and 7 days of follow up
the need for discontinuation of the antibiotic treatment
Time frame: during antibiotic treatment, an average of 10 days
the need for hospitalization to manage the diarrhea (in outpatients)
Time frame: during antibiotic treatment, an average of 10 days and 7 days of follow up
the need for intravenous rehydration in any of the study groups
Time frame: during antibiotic treatment, an average of 10 days and 7 days of follow up
adverse events
Time frame: during antibiotic treatment, an average of 10 days and 7 days of follow up
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 20 Mar 2018.
- Derived from this study: PubMed 28057659Kolodziej M, Szajewska H. Lactobacillus reuteri DSM 17938 in the prevention of antibiotic-associated diarrhoea in children: protocol of a randomised controlled trial. BMJ Open. 2017 Jan 5;7(1):e013928. doi: 10.1136/bmjopen-2016-013928.
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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 4 study testing Lactobacillus reuteri DSM 17938 in people with Diarrhea and Antibiotic Associated 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 3 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: finished, as of the sponsor's last update on 20 Mar 2018. 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 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?
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?
frequencies of diarrhea and antibiotic associated diarrhea (time frame: during antibiotic treatment, an average of 10 days and 7 days of follow up). 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 NCT02871908, 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 20 Mar 2018.