Health Condition 1: K580- Irritable bowel syndrome with diarrhea Health Condition 2: K580- Irritable bowel syndrome with diarrhea
Conditions
Interventions
Intervention1: Enterogermina®/Bacillus clausii /SSR29263: Enterogermina: 4 billion spores of Enterogermina per day (2 mini bottles per day, one in the morning and one in the evening) for a
period of
Sponsors
Sanofi Aventis Groupe
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Safety: adverse event (AEs), including serious adverse event (SAE), adverse event of special interest (AESI) physical examination, and vital signs -Frequency of stool per day - Dehydration status evaluated per WHO classificationTimepoint: 5 days | — |
Countries
India
Contacts
Public ContactMs Salini James
Sanofi-Synthelabo India Private Limited
Outcome results
None listed