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Efficacy and Safety of Probiotics in the Treatment of Acute Gastroenteritis in Children (SABINA)

Primary Purpose

Acute Gastroenteritis

Status
Completed
Phase
Phase 4
Locations
Argentina
Study Type
Interventional
Intervention
Probiotic : Saccharomyces boulardii
Probiotic : Bacillus clausii
Sponsored by
Biocodex
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Gastroenteritis

Eligibility Criteria

6 Months - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Instituto Medico
  • Instituto Medico
  • Instituto Medico
  • Consultario Privado 3
  • Consultorio Privado 1
  • Consultorio Privado 2
  • Consultorio Privado 4
  • Grupo Pediatrico

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Saccharomyces boulardii

Bacillus clausii

Arm Description

Floratil, 250 mg sachets, twice daily (1 in the morning and 1 in the evening) during 5 consecutive days.

Enterogermina, 5 ml vials, twice daily (1 in the morning and 1 in the evening) during 5 consecutive days.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 16, 2018
Last Updated
January 18, 2019
Sponsor
Biocodex
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1. Study Identification

Unique Protocol Identification Number
NCT03539913
Brief Title
Efficacy and Safety of Probiotics in the Treatment of Acute Gastroenteritis in Children
Acronym
SABINA
Official Title
Efficacy and Safety of Probiotics in the Treatment of Acute Gastroenteritis in Children
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 19, 2017 (Actual)
Primary Completion Date
June 9, 2018 (Actual)
Study Completion Date
June 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biocodex

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Gastroenteritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Allocation-blinded study
Allocation
Randomized
Enrollment
317 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Saccharomyces boulardii
Arm Type
Active Comparator
Arm Description
Floratil, 250 mg sachets, twice daily (1 in the morning and 1 in the evening) during 5 consecutive days.
Arm Title
Bacillus clausii
Arm Type
Active Comparator
Arm Description
Enterogermina, 5 ml vials, twice daily (1 in the morning and 1 in the evening) during 5 consecutive days.
Intervention Type
Biological
Intervention Name(s)
Probiotic : Saccharomyces boulardii
Intervention Description
Treatment for 5 days
Intervention Type
Biological
Intervention Name(s)
Probiotic : Bacillus clausii
Intervention Description
Treatment for 5 days
Primary Outcome Measure Information:
Title
Time frame in hours up to the time of the last liquid or loose stool as recorded in the stool diary
Description
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.
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carine FRANCOIS
Organizational Affiliation
Biocodex
Official's Role
Study Director
Facility Information:
Facility Name
Instituto Medico
City
Río Cuarto
State/Province
Provincia De Cordoba
Country
Argentina
Facility Name
Instituto Medico
City
San Juan
State/Province
Provincia De San Juan
Country
Argentina
Facility Name
Instituto Medico
City
San Miguel De Tucumán
State/Province
Tucuman
Country
Argentina
Facility Name
Consultario Privado 3
City
Caba
Country
Argentina
Facility Name
Consultorio Privado 1
City
Caba
Country
Argentina
Facility Name
Consultorio Privado 2
City
Caba
Country
Argentina
Facility Name
Consultorio Privado 4
City
Caba
Country
Argentina
Facility Name
Grupo Pediatrico
City
Caba
Country
Argentina

12. IPD Sharing Statement

Citations:
PubMed Identifier
36086703
Citation
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.
Results Reference
derived
PubMed Identifier
33295643
Citation
Collinson 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.
Results Reference
derived

Learn more about this trial

Efficacy and Safety of Probiotics in the Treatment of Acute Gastroenteritis in Children

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