Health Condition 1: null- Acute Diarrhoea Health Condition 2: R197- Diarrhea, unspecified
Conditions
Interventions
Intervention1: Gutgain: Probiotic containing the yeast Saccharomyces Boulardii and the bacteria Bacillus subtilis
Control Intervention1: Placebo: Identical looking Placebo having similar excipients as
Sponsors
Alkem Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects aged between 6 months - 5 years of either gender presenting with acute diarrhea of 2. Parent or legal guardian of the subjects /subject must give written informed consent for study participation. 3. Parent of the subjects must follow all instructions as per the protocol
Exclusion criteria
Exclusion criteria: 1. Subjects with clinical signs of dysentery, severe dehydration requiring hospitalization or parenteral fluid therapy. 2. Intake of any systemic antibiotic or any anti-diarrheal medication, in the previous 3 weeks prior to screening 3. Subjects who are debilitated or seriously ill or immunocompromised. 4. Subjects with symptoms or suspicion of an organic lesion of the digestive tract, or with undiagnosed abdominal pain or rectal bleeding or other GI disorder especially ulcerative colitis, Crohnâ??s disease, history of carcinomas of the bowel, malabsorption syndrome, intolerance to certain food types (lactose), functional diarrhea and functional constipation. 5. Use of probiotics in the last 3 weeks prior to baseline visit. 6. Current use of any drugs or treatments which is supposed to decrease the gastrointestinal motility or any other concomitant anti-diarrheal medication. 7. Subjects who have undergone ileostomy, jejunostomy or colostomy 8. Subjects with hypersensitivity to any ingredient in the formulation. 9. Subjects with coexisting features of acute systemic disease like septicemia, meningitis, pneumonia etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of diarrhea will be computed as time in hours after study product administration to the last abnormal (loose or liquid) stool preceding a normal stool output and the same would also be computed during the study period. Stool frequency will be noted as number of times the subject passes stool every day. Stool consistency will be evaluated on a 4 point Likert scale: 1- normal, 2- Loose, 3- semi-solid, 4 â?? liquid.Timepoint: 5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjects in both groups will be followed up 3 months post intervention to compare the incidence of acute diarrheal episodes between the test and placebo group.Timepoint: 3 months;The assessment of the safety of the study medications will be evaluated by monitoring of both serious (SAE) and non-serious solicited and unsolicited adverse events during the study period. Assessment of tolerability will be done by the physician on a 4 point Likert Scale 1- excellent, 2- good, 3- fair, 4- poor.Timepoint: 5 days | — |
Countries
India
Contacts
Public ContactDr Monjori Mitra
Medclin Research Pvt. Ltd.
Outcome results
None listed