Diarrhoea Digestive System Diarrhoea
Conditions
Interventions
1. LiveXtract solution mixed with ORS
2. Water mixed with ORS
Sponsors
LiveLeaf Inc
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Age 6 months old to 60 years old 2. Acute watery diarrhoea (for 48 hours or less)
Exclusion criteria
Exclusion criteria: 1. Fever 2. Bloody stool with or without abdominal pain 3. Clinical signs of coexisting severe acute systemic illness 4. Underlying severe chronic disease 5. Severe malnutrition 6. Signs of internal bleeding or black stools 7. Signs of drug abuse 8. Food allergy or other chronic gastrointestinal disease 9. Use of antibiotics or any anti-diarrhoeal medication during the previous 2 weeks 10. Any condition that the admitting physician believes will place the patient at risk if enrolled in the study 11. Participants whose stool cultures show Shigella spp 12. Unable or unwilling to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in the severity and duration of diarrhoea, measured as the time the stool is ranked as a 4 or less on the Bristol Stool Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Volume of ORS consumed from the time of randomisation to resolution of diarrhoea 2. Number of events and duration of emesis These outcomes will be monitored every 6 hours for 4 days and ranked with a Visual Analogue Scale of 0 to 10. | — |
Countries
Bangladesh
Outcome results
None listed