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

American University of Beirut Medical Center

Status: Terminated

Conditions: Acute Gastroenteritis

Treatments: Dietary Supplement: Lactose- free milk

Study type: Interventional

Funder types: Other

Identifiers

NCT02246010

PED.MN.09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 2 to 18 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Lactose-free milk

Experimental group

Description:

Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days.

Treatment:

Dietary Supplement: Lactose- free milk

Regular infant milk

No Intervention group

Description:

Regular infant milk formula and anti-diarrheic diet for 7 days.