NCT02246010

Lactose-free Milk in Infants With Acute Diarrhea in a Developing Country

Does Intake of Lactose-free Milk in Infants With Acute Gastroenteritis in a Developing Country Shorten the Duration of Diarrhea? A Randomized Clinical Trial.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: American University of Beirut Medical Center · Academic / Other
• Sex: All
• Age: 2 Months – 18 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether lactose-free milk will shorten the diarrhea duration and decrease its severity in formula-fed infants presenting to the Emergency Department (ED) or pediatric clinics with acute diarrhea.

Detailed description

Acute gastroenteritis is a major cause of pediatric morbidity and mortality accounting for 15 % of all childhood death worldwide, and is a major public health burden, especially in developing countries. A recent Cochrane review of 33 randomized or quasi-randomized trials reported a modest reduction in the duration of diarrhea in children younger than 5 years who were on reduced or lactose-free diet. Those trials however were conducted on inpatients in high or middle-income countries. None were from developing countries where diarrheal diseases are severer and result in higher morbidities and mortalities. This study aims at investigating the effect of lactose-free milk on the duration and severity of diarrhea in infants from a developing country, who present with acute gastroenteritis to the Emergency Department (ED) or pediatric clinics. The findings from this study will help provide evidence-based dietary recommendations for infants with acute diarrhea in developing countries who are treated in the ambulatory setting.

Conditions

• Acute Gastroenteritis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactose- free milk	Lactose- free milk

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-06-30
• Completion: 2017-06-30
• First posted: 2014-09-22
• Last updated: 2019-02-15
• Results posted: 2019-01-25

Locations

1 site across 1 country: Lebanon