Acute Gastroenteritis
Conditions
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.
Interventions
BIOLOGICALProbiotic : Saccharomyces boulardii
Treatment for 5 days
BIOLOGICALProbiotic : Bacillus clausii
Treatment for 5 days
Sponsors
Biocodex
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Allocation-blinded study
Eligibility
Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time frame in hours up to the time of the last liquid or loose stool as recorded in the stool diary | 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. |
Countries
Argentina
Outcome results
None listed