Overview

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.