Gastroenteritis
Conditions
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 children
Interventions
DRUGBacillus Clausii
For 5 days
For 5 days
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in duration of diarrhea | Throughout the treatment period |
| Incidence of adverse events | Throughout the study period |
Secondary
| Measure | Time frame |
|---|---|
| Vomiting episodes per day | Throughout the treatment period |
| Mean number of stools per day | Throughout the treatment period |
| Need for hospitalization | Throughout the treatment period |
| Requirement of unscheduled intravenous transfusion | Throughout the study period |
| Effect on consistency of stools | Throughtout the treatment period |
Countries
India
Outcome results
None listed