Diarrhoea Signs and Symptoms Diarrhoea
Conditions
Interventions
Eligible subjects will be randomised to one of two treatment arms to receive either reduced osmolarity ORS or reduced osmolarity ORS along with amylase resistant starch. All other treatment measures w
Sponsors
Christian Medical College (India)
Eligibility
Inclusion criteria
Inclusion criteria: In the adult study, all adult male patients presenting to the Emergency Service with acute severe watery diarrhoea of less than three days' duration, with moderate to severe dehydration, will be enrolled after informed written consent. In a separate trial, male children aged six months to five years with diarrhoea (defined as more than three watery stools/24 hours) of three days or less, with mild or moderate dehydration, or those with severe dehydration who have received intravenous rehydration, will be enrolled after informed written consent from the parent.
Exclusion criteria
Exclusion criteria: In the adult trial, subjects without clinical dehydration, those with presence of blood in stool, and presence of significant systemic illness unrelated to the diarrhoea, will be excluded. In the children's trial, bloody diarrhoea, concurrent severe illness (such as pneumonia, meningitis or infections requiring antibiotics), and severe malnutrition Grade III and IV will be treated as exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Stool weight in successive 12 hour periods 2. Stool weight in the second 24 hours 3. Time to last unformed stool 4. Requirement for unscheduled intravenous fluids | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
India
Outcome results
None listed