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

January 18, 2019 updated by: Biocodex

  • 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

317

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Caba, Argentina
        • Consultario Privado 3
      • Caba, Argentina
        • Consultorio Privado 1
      • Caba, Argentina
        • Consultorio Privado 2
      • Caba, Argentina
        • Consultorio Privado 4
      • Caba, Argentina
        • Grupo Pediatrico
    • Provincia De Cordoba
      • Río Cuarto, Provincia De Cordoba, Argentina
        • Instituto Medico
    • Provincia De San Juan
      • San Juan, Provincia De San Juan, Argentina
        • Instituto Medico
    • Tucuman
      • San Miguel De Tucumán, Tucuman, Argentina
        • Instituto Medico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Saccharomyces boulardii
Floratil, 250 mg sachets, twice daily (1 in the morning and 1 in the evening) during 5 consecutive days.
Biological: Probiotic : Saccharomyces boulardii
Treatment for 5 days
Active Comparator: Bacillus clausii
Enterogermina, 5 ml vials, twice daily (1 in the morning and 1 in the evening) during 5 consecutive days.
Biological: Probiotic : Bacillus clausii
Treatment for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biocodex

Investigators

  • Study Director: Carine FRANCOIS, Biocodex

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2017

Primary Completion (Actual)

June 9, 2018

Study Completion (Actual)

June 9, 2018

Study Registration Dates

First Submitted

May 16, 2018

First Submitted That Met QC Criteria

May 25, 2018

First Posted (Actual)

May 30, 2018

Study Record Updates

Last Update Posted (Actual)

January 22, 2019

Last Update Submitted That Met QC Criteria

January 18, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sb 184

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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