Enterogermina (Bacillus Clausii ) in the management of Diarrhea in childre
- Conditions
- Acute diarrheaMedDRA version: 17.1Level: LLTClassification code 10000706Term: Acute diarrheaSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2014-004636-19-Outside-EU/EEA
- Lead Sponsor
- Sanofi Aventis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 264
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
Are the trial subjects under 18? yes
Number of subjects for this age range: 264
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the efficacy of treatment with ORT in combination with<br>Bacillus clausii probiotic strain (Enterogermina™) as compared to<br>treatment with ORT alone, for a period of 5 days, in reducing the<br>duration of acute diarrhea in Indian children.;Secondary Objective: 1) To evaluate the clinical safety of Enterogermina™ in acute diarrhea in<br>children<br>2) To demonstrate the effect of Enterogermina™ on stool frequency<br>stool consistency number of vomiting episodes and hydration in children<br>suffering from acute diarrhea;Primary end point(s): Duration of diarrhea;Timepoint(s) of evaluation of this end point: From Day 1 to end of treatment visit (Day 6)
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: On each day (Day 1 to Day 6);Secondary end point(s): number of stools per day<br>consistency of stools<br>Number vomiting episodes per day <br><br>