ENterogermina® (Bacillus Clausii) In the manaGeMent of diarrheA in Children

Phase III Comparative Study to Assess the Efficacy and Safety of Oral Rehydration Therapy (ORT) in Combination With Spores of Bacillus Clausii (Enterogermina)Versus ORT Alone, Administered for 5 Days With the Treatment of Acute Diarrhea in Children.

Primary:

• To demonstrate the efficacy of Enterogermina® in reducing the duration of acute diarrhea in children

Secondary:

• To evaluate the safety of Enterogermina® in acute diarrhea in Indian children

Inclusion Criteria:

• Non hospitalised infants and children attending clinic/outpatients with acute diarrhea (>3 liquid or watery stools occurring in a 24-hour period) of less than 48 hours duration

Exclusion Criteria:

• History of presence of blood, pus, or mucus in stools
• Severe dehydration (World Health Organization criteria)
• Severely malnourished patients
• Treatment with antibiotics, probiotics, or prebiotics within a period of 2 weeks before enrolment
• History of conditions known to producing immunodeficiency (Acquired Immune Deficiency Syndrome, other congenital immunodeficiency syndrome, drug therapy with steroids, anticancer drugs etc)
• Known hypersensitivity to Bacillus clausii or other probiotics.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.