Esterified starch and oral rehydration solution as a treatment for acute infectious diarrhoea
Phase 2
Recruiting
- Conditions
- Acute infectious diarrhoeaOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colonInfection - Other infectious diseases
- Registration Number
- ACTRN12611000912987
- Lead Sponsor
- Christian Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Acute watery diarrhoea of less than three days’ duration and presence of dehydration.
Exclusion Criteria
Bloody diarrhoea
Concomitant illness including malignancy, sepsis, and a history of coronary artery disease or stroke.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of diarrhoea defined as time from commencing therapy to first formed stool or 12 hour period without stool. Stool form is assessed by a technician according to the Bristol stool form scale, and formed stool is defined as type IV stool in the scale.[Continuous variable, time from 0-72 hours];Stool weight in first 24 hours and total diarrhoea stool weight. Stool is collected in lined plastic containers and weighed every twelve hours on an electronic scale by a technician.[Measured every 12 hours till recovery or 72 hours]
- Secondary Outcome Measures
Name Time Method eed for unscheduled (i.e. after initial four hour rehydration period) intravenous fluids. Intravenous fluids are commenced if dehydration persists or worsens at the end of the first six hours of therapy, or dehydration reappears any time during subsequent course despite adequate intake of ORS.[Every 12 hour period till recovery or 72 hours.];Proportion of patients who recover from diarrhoea at 24 hours and at 48 hours. Recovery is defined as the passage of two consecutive formed stools (type IV on the Bristol stool form scale).[24 hours and 48 hours];Adverse events - serum sodium <120 mmol/L, serum creatinine >4 mg/dL, persistent vomiting[24 hours]