NCT03539913

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
317

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 19, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2018

Completed
Last Updated

January 22, 2019

Status Verified

January 1, 2019

Enrollment Period

12 months

First QC Date

May 16, 2018

Last Update Submit

January 18, 2019

Conditions

Acute Gastroenteritis

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 days

Study Arms (2)

Saccharomyces boulardii

ACTIVE COMPARATOR

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

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.

Biological: Probiotic : Bacillus clausii

Interventions

Probiotic : Saccharomyces boulardiiBIOLOGICAL

Treatment for 5 days

Saccharomyces boulardii
Probiotic : Bacillus clausiiBIOLOGICAL

Treatment for 5 days

Bacillus clausii

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Instituto Medico

Río Cuarto, Córdoba Province, Argentina

Location

Instituto Medico

San Juan, San Juan Province, Argentina

Location

Instituto Medico

San Miguel de Tucumán, Tucumán Province, Argentina

Location

Consultario Privado 3

CABA, Argentina

Location

Consultorio Privado 1

CABA, Argentina

Location

Consultorio Privado 2

CABA, Argentina

Location

Consultorio Privado 4

CABA, Argentina

Location

Grupo Pediatrico

CABA, Argentina

Location

Related Publications (2)

  • 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.

    PMID: 36086703DERIVED

  • 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.

    PMID: 33295643DERIVED

Study Officials

  • Carine FRANCOIS

    Biocodex

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Allocation-blinded study
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2018

First Posted

May 30, 2018

Study Start

June 19, 2017

Primary Completion

June 9, 2018

Study Completion

June 9, 2018

Last Updated

January 22, 2019

Record last verified: 2019-01

Locations

AR(8)