Assessment of the impact of oral Human Milk Oligosaccharides (HMO) application on acute diarrhoea and the development of prolonged and persistent diarrhoea in paediatric patients hospitalized with acute diarrhoea.
The trial is single site, double blind, randomized of HMO addition (1.5 g /day) to standard of care in paediatric diarrhoea patients. HMO application and follow-up of the children at home will be done for 2 weeks. Control patients receive only the standard of care (ORS plus zinc). A breastfed group of diarrhoea patients will serve as reference group. The total sample size is 495 patients. Patients will be females and males aged 6 months to 2 years old with acute diarrhoea.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
435
International Center for Diarrheal Disease Research
Dhaka, Bangladesh
Improvement (change) of clinical symptoms of diarrhea
Passage of the last abnormal stool prior to formed/ soft stools during two consecutive 8-hour periods.
Time frame: Day1, Day2, Day3, Day4, Day5, Day6, Day7
Stools output
Stools output, expressed as g/kg of body weight (cumulative output)
Time frame: Day1, Day2, Day3, Day4, Day5, Day6, Day7
Weight gain
Time frame: Day1, Day2, Day3, Day4, Day5, Day6, Day7, Day14
Adverse events
Time frame: Day1, Day2, Day3, Day4, Day5, Day6, Day7, Day14
Daily stool frequency
Time frame: Day1, Day2, Day3, Day4, Day5, Day6, Day7
The number of vomiting
Time frame: Day1, Day2, Day3, Day4, Day5, Day6, Day7
The duration of vomiting
Time frame: Day1, Day2, Day3, Day4, Day5, Day6, Day7
Change in Z-score
Time frame: Day1, Day14
The amount of ORS to correct dehydration expressed as ml ORS /kg body weight, daily and cumulative input
Time frame: Day1, Day2, Day3, Day4, Day5, Day6, Day7
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.