Health Condition 1: null- Acute Childhood Diarrhoea Health Condition 2: B962- Escherichia coli [E. coli ] as thecause of diseases classified elsewhere
Conditions
Interventions
Intervention1: S. boulardii plus ORS and Zinc: S. boulardii (strain CNCM I-3799) ("LesunBerry") plus standard treatment containing ORS and Zinc
Control Intervention1: ORS, Zinc and Maltodextrin: Stand
Sponsors
Investigator initiated trial
Sundyota Numandis Pharmaceuticals Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: (1) Male and,or female children of age 3 months to 36 months (both inclusive) with acute diarrhoea. (2) Child having three or more loose stools in last 24 hrs. (3) Subjects parent(s) or legal guardian are willing to provide informed consent form and also willing to comply with all the study requirements.
Exclusion criteria
Exclusion criteria: -Dysentery (presence of visible blood in stools) -Clinical evidence of coexisting any acute systemic illness (for e.g. meningitis, sepsis, pneumonia) -Clinical evidence of chronic disease (for e.g. chronic liver disease, chronic renal disease, nephrotic syndrome) -Known case of chronic gastrointestinal disease like celiac disease or inflammatory bowel disease -Use of probiotics in previous week -Use of antibiotics or an other anti-diarrhoeal medication for the current episode of diarrhoea in previous week. -Invasive diarrhoea -Clinical evidence of severe malnutrition based on weight-for-Length less than 3 SD of WHO Reference Card -Severe dehydration (shock with diminished consciousness, lack of urine output, cool, moist extremities, a rapid and feeble pulse, low or undetectable blood pressure and pale skin) -Participation in any other clinical study during last 30 days -Children with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time of recovery from diarrhoea, (Duration of Diarrhoea based on consistency of stool (3 consecutive semi solid stool formed) or no stool in last 12 hr considered as recovery from diarrhoea.)Timepoint: 05 days | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Frequency of stool (2) Frequency of vomiting (3) Total ORS consumption (4) Date and time of first semi solid stool (5) Time of first rehydration (6) Consistency of stools (7) Number of relapses (8) Duration of relapses episodes Timepoint: 65 days | — |
Countries
India
Contacts
Public ContactDr Milan Satia
Hitarth Children Hospital and Neonatal Care Unit
Outcome results
None listed