Efficacy and Safety of Probiotics in the Treatment of Acute Gastroenteritis in Children

Efficacy and Safety of Probiotics in the Treatment of Acute Gastroenteritis in Children

• 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.

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