Additive effect of resistant starch on oral rehydration therapy and zinc supplementation for children with acute diarrhoea

INTERVENTION: Consecutive children presenting to the paediatric emergency room or outpatient clinics at CMC Hospital and CHAD, and fulfilling inclusion criteria, will be offered entry into the study. The admitting paediatrician together with a study nurse or study doctor will obtain informed consent from a parent or legal guardian upon admission. Those children for whom informed consent is obtained will be randomised to one of two treatment arms: 1. Standard ORS and zinc supplementation (control group) 2. HAMS‐ORS and Zinc supplementation (experimental group) Children with severe dehydration will also be treated with three to six hours of intravenous fluids as per WHO treatment plan C. Those children with severe dehydration who are not adequately rehydrated after the initial three to six hours of intravenous fluids, and require further intravenous hydration at this time will be excluded from the study. Study numbers for each arm will be generated using a table of random numbers in blocks of ten patients. For practical reasons, subjects at CMC Hospital and CHAD Hospital will have site‐specific randomisation blocks and distinct study numbers. Packets containing one of the two different therapies will be sealed with opaque covers bearing serial study numbers; children will be designated to treatment arms by the packet that they receive. Treatment will be prepared and administered by study nurses. Standard ORS will be formulated according to WHO recommendations (sodium 75 mEq/L, potassium 20 mEq/L, chloride 65 mEq/L, glucose 75 mmol/L, citrate 10 mmol/L, osmolarity 245 mOsm/L) by adding a pre‐formulated packet to 200 ml water. HAMS‐ORS will have 10 g HAMS added to each 200 ml of standard ORS, yielding 50 g/L of HAMS. 20 mg zinc sulfate syrup (20 mg in 5 ml) will be administered to each child daily until cessation of diarrhoea. Children will be offered ORS (standard ORS or HAMS‐ORS) according to the appropriate WHO treatment plan based on their level of dehydration. As is st CONDITION: Acute infectious diarrhoea ; Infections and Infestations ; Infectious diarrhoea PRIMARY OUTCOME: Diarrhoeal duration, defined as time from the start of ORS consumption to the last unformed stool, or the last stool prior to a 12 hour period without any bowel movement. SECONDARY OUTCOME: 1. Stool frequency; 2. Diarrhoeal stool output measured by weight. This will be measured only in male children; due to anatomical considerations only male children can have urine collected separately in a urine pouch so that accurate stool weights collected can be measured in pre‐weighed diapers; 3. Proportion of children who recover from diarrhoea by 24 hours and 48 hours; 4. The need for unscheduled intravenous hydration for recurrent severe dehydration; 5. Adverse events INCLUSION CRITERIA: 1. Age six months to three years with acute diarrhoea, defined as more than three episodes of watery stools in the last 24 hours 2. Clinically detectable dehydration to warrant hospital treatment