NCT02896465

Human Milk Oligosaccharides and Childhood Diarrhoea

Treatment of Acute Childhood Diarrhoea With Human Milk Oligosaccharides and Impact on Gut Micro Biota Dysbiosis and Nutritional Status

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 435 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 6 Months – 2 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Diarrhea

Interventions

Type	Name	Description
OTHER	Oral rehydration solution
OTHER	Zinc
OTHER	Human milk oligosaccharides
OTHER	Breastfeeding

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-10-01
• Completion: 2019-02-01
• First posted: 2016-09-12
• Last updated: 2019-07-23

Locations

1 site across 1 country: Bangladesh