Clinical trial NCT02246010: Lactose-free Milk in Infants With Acute Diarrhea in a Developing Country
Official title: Does Intake of Lactose-free Milk in Infants With Acute Gastroenteritis in a Developing Country Shorten the Duration of Diarrhea? A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Gastroenteritis
Keywords: diarrhea
developing world
lactose-free diet
Clinical trial
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2014-09-22
Enrollment: 6
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Infants on artificial milk formula
* Presenting to the ED or pediatric clinics of the American University of Beirut Medical Center
* Chief complaint: acute gastroenteritis (three or more loose or liquid stools in 24 hours, for at least 24 hours, and not exceeding 2 weeks from presentation, with or without fever, vomiting, mucus or blood per stools).

Exclusion Criteria:

* Exclusively or partially breast-fed infants
* Severe dehydration requiring hospitalization

Primary outcomes:
measure: Diarrhea Duration
timeFrame: From onset of illness till the day of last diarrheic stool passed.
Secondary outcomes:
measure: Weight Loss
timeFrame: 7 days
measure: Illness Visits
timeFrame: 7 days
measure: Hospitalization Rate
timeFrame: 7 days
measure: Parental Satisfaction
timeFrame: 7 days
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
Study officials:
References:
citation: Nabulsi M, Yazbeck N, Charafeddine F. Lactose-free milk for infants with acute gastroenteritis in a developing country: study protocol for a randomized controlled trial. Trials. 2015 Feb 8;16:46. doi: 10.1186/s13063-015-0565-9.