None listed
Conditions
Interventions
Intervention1: Lactospore�® (Bacillus coagulans MTCC 5856 Spores): 4 Hundred Million Bacillus coagulans MTCC 5856 CFU + ORS + Zinc, twice daily for 5days
Control Intervention1: Placebo (Maltodext
Sponsors
Sami Sabinsa Group Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Children aged 1 to 10 years diagnosed with acute diarrhea. 2.Children who experienced more than 3 watery stools within last 24 hours. 3.Signed informed consent from one of the parents/legal guardians. 4.Children aged above 7 years willing to provide verbal assent will be counter signed by Parents. 5.Parentsââ?¬•/legal guardiansââ?¬• willing to comply with all its procedures.
Exclusion criteria
Exclusion criteria: 1.Subjects who require antibiotics treatment. 2.Subject who require intravenous fluid therapy. 3.Severe diarrhea which requires treatment other than ORS. 4.Severe dehydration as per WHO dehydration scale. 5.Immunodeficiency. 6.Malnourished (weight for height 7.Surgery within one month prior to inclusion. 8.Children suffering from severe chronic illness. 9.Chronic pathologies (e.g.: cardiopathies, nephropathies, chronic gastrointestinal pathologies, endocrinopathies). 10.No consumption of commercial products containing probiotics including Yakult, during the study period. 11.Participation in any other clinical trial within 4 weeks prior to entry into the study. 12.Children Hospitalized for Pneumonia and acute gastroenteritis. 13.Children having bilious vomiting, hematochezia, pancreatic dysfunction or insufficiency judged by medical history.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a)Mean duration of 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) b)Mean diarrhea frequency per day after initiation of treatment Timepoint: 1 Day 3 & Day 5 2 Day 3 & Day 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| a)Perceived efficacy among caregivers per perceived efficacy scale. b)Dehydration status evaluated as per WHO classification. c)Occurrence of adverse events. Timepoint: Day 3 & Day 5 | — |
Countries
India
Contacts
Public ContactDr Alphons Philips
Sami-Sabinsa Group Limited
Outcome results
None listed