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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi

Criteria

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.