Efficacy and Safety of Enterogermina vs Placebo in Combination with ORT and Zinc for 5 Days Treatment in Children with Acute Diarrhea in India
- Conditions
- Health Condition 1: K580- Irritable bowel syndrome with diarrheaHealth Condition 2: K580- Irritable bowel syndrome with diarrhea
- Registration Number
- CTRI/2018/10/016053
- Lead Sponsor
- Sanofi Aventis Groupe
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 457
1 6 months less or equal to Age less than or equal to 5 years old
2 Suffering from acute diarrhea of less than 48 hours duration, Diarrhea is defined as unusual loose or watery stools at least 3 times in previous 24 hours period with no signs of dehydration or some dehydration WHO classification
3 Whose parent or legal guardian has given a written informed consent to participate for his or her child in the study at the time of enrollment
1 Known hypersensitivity to B clausii or any of the excipients or other probiotics
2 Children suffering from chronic GI disease as Crohnâ??s disease, hemorrhagic recto colitis, irritable bowel syndrome, short gut syndrome and inflammatory bowel disease
3 History of or current presence of blood hematochezia, pus, or mucus in stools within the previous 3 months
4 Persistent diarrhea a diarrhea episode which lasts more than 14 days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of acute diarrhea (expressed in hours), as counted from the time of randomization up to recovery (the first normal stool as recorded according to Bristol score; a score 5 is described as normalization of stool)Timepoint: Duration of acute diarrhea (expressed in hours), as counted from the time of randomization up to recovery (the first normal stool as recorded according to Bristol score; a score 5 is described as normalization of stool)
- Secondary Outcome Measures
Name Time Method Safety: adverse event (AEs), including serious adverse <br/ ><br>event (SAE), adverse event of special interest (AESI) <br/ ><br>physical examination, and vital signs <br/ ><br>-Frequency of stool per day <br/ ><br>- Dehydration status evaluated per WHO classificationTimepoint: 5 days