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Does Intake of Lactose-free Milk in Infants With Acute Gastroenteritis in a Developing Country Shorten the Duration of Diarrhea? A Randomized Clinical Trial.
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.
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.
Age
0 - 1 years
Sex
ALL
Healthy Volunteers
No
American University of Beirut Medical Center
Beirut, Lebanon
Start Date
July 1, 2015
Primary Completion Date
June 30, 2017
Completion Date
June 30, 2017
Last Updated
February 15, 2019
6
ACTUAL participants
Lactose- free milk
DIETARY_SUPPLEMENT
Lead Sponsor
American University of Beirut Medical Center
NCT07342088
NCT06516692
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT02902445