Status:
COMPLETED
ENterogermina® (Bacillus Clausii) In the manaGeMent of diarrheA in Children
Lead Sponsor:
Sanofi
Conditions:
Gastroenteritis
Eligibility:
All Genders
6-5 years
Phase:
PHASE3
Brief 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 chi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT00457353
Start Date
March 1 2007
Last Update
January 21 2009
Active Locations (1)
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1
Sanofi-Aventis
Mumbai, India