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

Biocodex

Status and phase

Completed

Phase 4

Conditions

Acute Gastroenteritis

Treatments

Biological: Probiotic : Saccharomyces boulardii

Biological: Probiotic : Bacillus clausii

Study type

Interventional

Funder types

Industry

Identifiers

Sb 184

Details and patient eligibility

About

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.

Enrollment

317 patients

Sex

All

Ages

6 months to 5 years old

Volunteers

No 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