Clinical trial NCT03539913: Efficacy and Safety of Probiotics in the Treatment of Acute Gastroenteritis in Children
Official title: Efficacy and Safety of Probiotics in the Treatment of Acute Gastroenteritis in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Gastroenteritis
Lead sponsor: Biocodex
Sponsor class: INDUSTRY
First posted: 2018-05-30
Enrollment: 317
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Time frame in hours up to the time of the last liquid or loose stool as recorded in the stool diary
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Río Cuarto
country: Argentina
facility: Instituto Medico
state: Provincia De Cordoba
city: San Juan
country: Argentina
facility: Instituto Medico
state: Provincia De San Juan
city: San Miguel De Tucumán
country: Argentina
facility: Instituto Medico
state: Tucuman
city: Caba
country: Argentina
facility: Consultario Privado 3
city: Caba
country: Argentina
facility: Consultorio Privado 1
city: Caba
country: Argentina
facility: Consultorio Privado 2
city: Caba
country: Argentina
facility: Consultorio Privado 4
city: Caba
country: Argentina
facility: Grupo Pediatrico
Study officials:
affiliation: Biocodex
name: Carine FRANCOIS
role: STUDY_DIRECTOR
References:
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.
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.