Acute GastroenteritisPhase 4SABINANCT03539913
Efficacy and Safety of Probiotics in the Treatment of Acute Gastroenteritis in Children
A Phase 4 study testing Probiotic : Saccharomyces boulardii and Probiotic : Bacillus clausii in people with Acute Gastroenteritis, run by Biocodex at 8 sites in Argentina.
Trial summary
Primary Objective: o To assess the efficacy of the probiotics in reducing the duration of diarrhea in children suffering from acute gastroenteritis. Secondary Objectives: To assess the efficacy of the probiotics in improving the frequency and consistency of stools. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Acute Gastroenteritis
- What is being tested?
- Probiotic : Saccharomyces boulardii and Probiotic : Bacillus clausii
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 317 participants
- Where
- 8 sitesArgentina
- Study dates
- 19 Jun 2017to 9 Jun 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 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of both gender aged between 6 months and 5 years
- Presenting with acute diarrhea (3 or more loose or liquid stools in a 24-hour period) since at least the last 24h but less than 5 days
- Signed informed consent of the legal representatives obtained before any study procedure
- Parents able to fulfill in the stool diary according to the physician's opinion.
Who cannot join
- Unable to take medication and fluids by mouth
- More than 50% breastfeeding
- Severe malnutrition, defined by a ratio weight/height at/or below -3SD
- Severe dehydration, defined by a need of IV rehydration
- Chronic underlying disease, including but not limited to severe gastrointestinal disorder, immunocompromised condition or systemic infection
- Use of prohibited treatments
- Contra-indications to the studied probiotics
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Argentina8 sites
Consultario Privado 3
CABA
Consultorio Privado 1
CABA
Consultorio Privado 2
CABA
Consultorio Privado 4
CABA
Grupo Pediatrico
CABA
Instituto Medico
Río Cuarto, Córdoba Province
Instituto Medico
San Juan, San Juan Province
Instituto Medico
San Miguel de Tucumán, Tucumán Province
About this study
- Primary Objective:
- To assess the efficacy of the probiotics in reducing the duration of diarrhea in children suffering from acute gastroenteritis.
- Secondary Objectives:
- To assess the efficacy of the probiotics in improving the frequency and consistency of stools.
- To assess the efficacy of the probiotics in avoiding recurrence of diarrhea.
- To assess the efficacy of the probiotics on the disease severity.
- To assess the safety and tolerability of the studied probiotics.
- Conditions
- Acute Gastroenteritis
- Being tested
- Probiotic : Saccharomyces boulardii, Probiotic : Bacillus clausii
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic : Saccharomyces boulardiiBiological
Treatment for 5 days
Probiotic : Bacillus clausiiBiological
Treatment for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Saccharomyces boulardii | Active comparator | Floratil, 250 mg sachets, twice daily (1 in the morning and 1 in the evening) during 5 consecutive days. Receives: Biological: Probiotic : Saccharomyces boulardii |
| Bacillus clausii | Active comparator | Enterogermina, 5 ml vials, twice daily (1 in the morning and 1 in the evening) during 5 consecutive days. Receives: Biological: Probiotic : Bacillus clausii |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time frame in hours up to the time of the last liquid or loose stool as recorded in the stool diary
Time frame in hours up to the time of the last liquid or loose stoll (defined as type 6 or 7 on Bristol Stool Scale) followed by the first 24-hour period with stool consistency improvement (no liquid or loose stool), i.e. cessation of diarrhea as recorded by the parents in the stool diary.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start19 Jun 2017
- Primary completion9 Jun 2018
- Study completion9 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocodex
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carine FRANCOIS, Study director, Biocodex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539913
- Sponsor's protocol ID
- Sb 184
- Acronym
- SABINA
- Status last verified
- Jan 2019
- First submitted
- 16 May 2018
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Altcheh J, Carosella MV, Ceballos A, D'Andrea U, Jofre SM, Marotta C, Mugeri D, Sabbaj L, Soto A, Josse C, Montestruc F, McFarland LV. Randomized, direct comparison study of Saccharomyces boulardii CNCM I-745 versus multi-strained Bacillus clausii probiotics for the treatment of pediatric acute gastroenteritis. Medicine (Baltimore). 2022 Sep 9;101(36):e30500. doi: 10.1097/MD.0000000000030500.
PubMed 36086703Collinson S, Deans A, Padua-Zamora A, Gregorio GV, Li C, Dans LF, Allen SJ. Probiotics for treating acute infectious diarrhoea. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD003048. doi: 10.1002/14651858.CD003048.pub4.
PubMed 33295643
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Probiotics in the Treatment of Acute Gastroenteritis in Children
- ClinicalTrials.gov ID
- NCT03539913
- Acronym / sponsor ID
- SABINA / Sb 184
- Conditions
- Acute Gastroenteritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- BiocodexIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 9 Jun 2018 (actual)
- Study completion
- 9 Jun 2018 (actual)
- First posted
- 30 May 2018 (actual)
- 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.
- Primary Objective:
- To assess the efficacy of the probiotics in reducing the duration of diarrhea in children suffering from acute gastroenteritis.
- Secondary Objectives:
- To assess the efficacy of the probiotics in improving the frequency and consistency of stools.
- To assess the efficacy of the probiotics in avoiding recurrence of diarrhea.
- To assess the efficacy of the probiotics on the disease severity.
- To assess the safety and tolerability of the studied probiotics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saccharomyces boulardii | Active comparator | Biological: Probiotic : Saccharomyces boulardiiFloratil, 250 mg sachets, twice daily (1 in the morning and 1 in the evening) during 5 consecutive days. |
| Bacillus clausii | Active comparator | Biological: Probiotic : Bacillus clausiiEnterogermina, 5 ml vials, twice daily (1 in the morning and 1 in the evening) during 5 consecutive days. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children of both gender aged between 6 months and 5 years
- Presenting with acute diarrhea (3 or more loose or liquid stools in a 24-hour period) since at least the last 24h but less than 5 days
- Signed informed consent of the legal representatives obtained before any study procedure
- Parents able to fulfill in the stool diary according to the physician's opinion.
Key exclusion criteria (7 listed)
- Unable to take medication and fluids by mouth
- More than 50% breastfeeding
- Severe malnutrition, defined by a ratio weight/height at/or below -3SD
- Severe dehydration, defined by a need of IV rehydration
- Chronic underlying disease, including but not limited to severe gastrointestinal disorder, immunocompromised condition or systemic infection
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 |
|---|---|---|
| Probiotic : Saccharomyces boulardiiTreatment for 5 days | Biological | Saccharomyces boulardii |
| Probiotic : Bacillus clausiiTreatment for 5 days | Biological | Bacillus clausii |
Primary outcome
Time frame in hours up to the time of the last liquid or loose stool as recorded in the stool diary
Time frame: 5 days
Time frame in hours up to the time of the last liquid or loose stoll (defined as type 6 or 7 on Bristol Stool Scale) followed by the first 24-hour period with stool consistency improvement (no liquid or loose stool), i.e. cessation of diarrhea as recorded by the parents in the stool diary.
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 22 Jan 2019.
- Derived from this study: PubMed 36086703Altcheh J, Carosella MV, Ceballos A, D'Andrea U, Jofre SM, Marotta C, Mugeri D, Sabbaj L, Soto A, Josse C, Montestruc F, McFarland LV. Randomized, direct comparison study of Saccharomyces boulardii CNCM I-745 versus multi-strained Bacillus clausii probiotics for the treatment of pediatric acute gastroenteritis. Medicine (Baltimore). 2022 Sep 9;101(36):e30500. doi: 10.1097/MD.0000000000030500.
- Derived from this study: PubMed 33295643Collinson S, Deans A, Padua-Zamora A, Gregorio GV, Li C, Dans LF, Allen SJ. Probiotics for treating acute infectious diarrhoea. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD003048. doi: 10.1002/14651858.CD003048.pub4.
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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.
Carine FRANCOIS study director
Biocodex
8 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 Probiotic : Saccharomyces boulardii and Probiotic : Bacillus clausii in people with Acute Gastroenteritis, run by Biocodex at 8 sites in Argentina.
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 4 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 22 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 8 sites in Argentina. 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 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?
Time frame in hours up to the time of the last liquid or loose stool as recorded in the stool diary (time frame: 5 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 NCT03539913, which also lists 2 linked publications.
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 22 Jan 2019.