Acute GastroenteritisNCT02989350
Efficacy of Lactobacillus Reuteri DSM 17938 for the Treatment of Acute Gastroenteritis in Children
A study testing Lactobacillus reuteri DSM 17938 in people with Acute Gastroenteritis, run by Szpital im. Św. Jadwigi Śląskiej at 1 site in Poland.
Trial summary
Acute gastroenteritis (AGE) is one of the most common diseases among children. Oral rehydration therapy is the key treatment. According to the 2014 guidelines developed by the ESPGHAN probiotics may be considered in the management of children with AGE in addition to rehydration therapy. Read more about this study
- Who is it for?
- Ages 2 to 60 months
- Conditions the study is for
- Acute Gastroenteritis
- What is being tested?
- Lactobacillus reuteri DSM 17938
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 16 Jan 2017to Nov 2018
- Phase
- Interventional
- 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 2 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Acute gastroenteritis (AGE) defined as a change in stool consistency to loose or liquid form (according to the Bristol Stool Form (BSF) scale or in the case of infants, the Amsterdam Stool Form (ASF) scale) and/or an increase in the frequency of evacuations (typically ≥3 in 24 h), lasting for no longer than 5 days.
- Age: older than 1 month and younger than 60 months.
- A caregiver must provide written informed consent.
Who cannot join
- Use of antibiotics within two weeks prior to enrolment.
- Use of gelatine tannate, diosmectite, probiotics, racecadotril, or zinc (including zinc containing ORS) within a week prior to enrolment (a single dose is allowed).
- Breast feeding (>50%)
- Chronic diarrhoeal gastrointestinal disease (e.g., inflammatory bowel disease, cystic fibrosis, coeliac disease, food allergy)
- Immunodeficiency
- Malnutrition (weight/height/length under 3rd percentile) (WHO Child Growth Standards will be used)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Lactobacillus Reuteri DSM 17938 for the Treatment of Acute Gastroenteritis in Children: Randomised Controlled Trial
Acute gastroenteritis (AGE) is one of the most common diseases among children. Oral rehydration therapy is the key treatment. According to the 2014 guidelines developed by the ESPGHAN probiotics may be considered in the management of children with AGE in addition to rehydration therapy. Considering that evidence on L reuteri remains limited, the investigators aim to assess the efficacy of L reuteri DSM 17938 for the treatment of AGE in children. Children vaccinated and not vaccinated against rotavirus will be evaluated separately.
Two independent reports (rotavirus-vaccinated and non-vaccinated children) are planned.
- Conditions
- Acute Gastroenteritis
- Being tested
- Lactobacillus reuteri DSM 17938, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus reuteri DSM 17938Dietary supplement
Lactobacillus reuteri DSM 17938 vs Placebo
PlaceboDietary supplement
Lactobacillus reuteri DSM 17938 vs Placebo
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus reuteri DSM 17938 | Active comparator | 2 x 10(8) CFU. Both L reuteri DSM 17938 and placebo will be taken orally, twice daily 5 drops, for consecutive 5 days. Receives: Dietary Supplement: Lactobacillus reuteri DSM 17938 |
| Placebo | Placebo comparator | Placebo consists of an identical formulation, except active substance. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of diarrhea
(measured in hours) - time until the normalisation of stool consistency according to the Bristol Stool Form Scale(BSF) or Amsterdam Infant Stool Scale (ASF) - (in BSF scale, numbers 1, 2, 3, 4 and 5; in ASF scale, letters B or C), or the time until the normalisation of the number of stools (compared with the period before the onset of diarrhoea).and the presence of normal stools for 48 h.
Measured: 8 days
Secondary outcomes (9)
Need for intravenous rehydration
Number of patients in each group requiring intravenous rehydration
Measured: 8 days
Duration of intravenous rehydration
Measured: 8 days
Need for hospitalisation of outpatients
Number of patients enrolled as outpatient requiring hospitalisation - based on medical assesment
Measured: 8 days
Number of watery stools per day
Measured: 8 days
Vomiting
Number of participants with vomits and number of vomits per day
Measured: 8 days
Recurrence of diarrhoea (in 48 hours after intervention)
Number of patients in which diarrhoea recur after initial recovery in 48 hours
Measured: 48 hours
Severity of diarrhoea according to Vesikari scale
Measured: 8 days
Use of concomitant medications
Measured: 8 days
Adverse events
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study start16 Jan 2017
- Primary completionNov 2018
- Study completionNov 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 Acute GastroenteritisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Szpital im. Św. Jadwigi Śląskiej
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henryk Szymański, Szpital im. Św. Jadwigi Śląskiej
- Investigators
- Henryk Szymański, MD PhD, Principal investigator, Szpital im.Świętej Jadwigi Śląskiej, Trzebnica, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989350
- Sponsor's protocol ID
- 1/2016
- Status last verified
- Jan 2019
- First submitted
- 1 Dec 2016
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Szymanski H, Szajewska H. Efficacy of Lactobacillus Reuteri DSM 17938 for the Treatment of Acute Gastroenteritis in Children: Protocol of a Randomized Controlled Trial. JMIR Res Protoc. 2017 Aug 23;6(8):e164. doi: 10.2196/resprot.7924.
PubMed 28835355
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lactobacillus Reuteri DSM 17938 for the Treatment of Acute Gastroenteritis in Children: Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02989350
- Acronym / sponsor ID
- 1/2016
- Conditions
- Acute Gastroenteritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Szpital im. Św. Jadwigi ŚląskiejUniversity, hospital or other
- Study start
- 16 Jan 2017 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 12 Dec 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.
Acute gastroenteritis (AGE) is one of the most common diseases among children. Oral rehydration therapy is the key treatment. According to the 2014 guidelines developed by the ESPGHAN probiotics may be considered in the management of children with AGE in addition to rehydration therapy. Considering that evidence on L reuteri remains limited, the investigators aim to assess the efficacy of L reuteri DSM 17938 for the treatment of AGE in children. Children vaccinated and not vaccinated against rotavirus will be evaluated separately.
Two independent reports (rotavirus-vaccinated and non-vaccinated children) are planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus reuteri DSM 17938 | Active comparator | Dietary Supplement: Lactobacillus reuteri DSM 179382 x 10(8) CFU. Both L reuteri DSM 17938 and placebo will be taken orally, twice daily 5 drops, for consecutive 5 days. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo consists of an identical formulation, except active substance. |
Who may qualify
- Ages
- 2 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Acute gastroenteritis (AGE) defined as a change in stool consistency to loose or liquid form (according to the Bristol Stool Form (BSF) scale or in the case of infants, the Amsterdam Stool Form (ASF) scale) and/or an increase in the frequency of evacuations (typically ≥3 in 24 h), lasting for no longer than 5 days.
- Age: older than 1 month and younger than 60 months.
- A caregiver must provide written informed consent.
Key exclusion criteria (6 listed)
- Use of antibiotics within two weeks prior to enrolment.
- Use of gelatine tannate, diosmectite, probiotics, racecadotril, or zinc (including zinc containing ORS) within a week prior to enrolment (a single dose is allowed).
- Breast feeding (>50%)
- Chronic diarrhoeal gastrointestinal disease (e.g., inflammatory bowel disease, cystic fibrosis, coeliac disease, food allergy)
- Immunodeficiency
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 vs Placebo | Dietary supplement | Lactobacillus reuteri DSM 17938 |
| PlaceboLactobacillus reuteri DSM 17938 vs Placebo | Dietary supplement | Placebo |
Primary outcome
Duration of diarrhea
Time frame: 8 days
(measured in hours) - time until the normalisation of stool consistency according to the Bristol Stool Form Scale(BSF) or Amsterdam Infant Stool Scale (ASF) - (in BSF scale, numbers 1, 2, 3, 4 and 5; in ASF scale, letters B or C), or the time until the normalisation of the number of stools (compared with the period before the onset of diarrhoea).and the presence of normal stools for 48 h.
9 secondary outcomes
Need for intravenous rehydration
Time frame: 8 days
Duration of intravenous rehydration
Time frame: 8 days
Need for hospitalisation of outpatients
Time frame: 8 days
Number of watery stools per day
Time frame: 8 days
Vomiting
Time frame: 8 days
Recurrence of diarrhoea (in 48 hours after intervention)
Time frame: 48 hours
Severity of diarrhoea according to Vesikari scale
Time frame: 8 days
Use of concomitant medications
Time frame: 8 days
Adverse events
Time frame: 8 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 30 Jan 2019.
- Derived from this study: PubMed 28835355Szymanski H, Szajewska H. Efficacy of Lactobacillus Reuteri DSM 17938 for the Treatment of Acute Gastroenteritis in Children: Protocol of a Randomized Controlled Trial. JMIR Res Protoc. 2017 Aug 23;6(8):e164. doi: 10.2196/resprot.7924.
- published protocolLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Gastroenteritis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Not yet recruitingObservational study
Cardiovascular Risk in Patients With IBD
Ulcerative Colitis (UC), Crohn's Diseases
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
Not yet recruiting
Automatic Versus As-Needed Follow-up After Hospitalization for Children With Medical Complexity
Children With Medical Complexity, Respiratory Tract Infections (RTI)
Not yet recruitingPhase 2
Patient Choice Between Antibiotics and Appendectomy in Uncomplicated Appendicitis (FRENCH 47 - ALACARTE)
Acute Appendicitis
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.
Henryk Szymański, MD PhD principal investigator
Szpital im.Świętej Jadwigi Śląskiej, Trzebnica, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus reuteri DSM 17938 in people with Acute Gastroenteritis, run by Szpital im. Św. Jadwigi Śląskiej 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 6 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 30 Jan 2019. 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.
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?
Duration of diarrhea (time frame: 8 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 NCT02989350, 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 30 Jan 2019.