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

Not Applicable

Terminated

• Conditions: Acute Gastroenteritis

• Registration Number: NCT02246010
• Lead Sponsor: American University of Beirut Medical Center

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.

Study Timeline

• Study First Submitted: 2014-09-18
• Study First Submitted QC: 2014-09-19
• Study First Posted: 2014-09-22
• Study Start: 2015-07-01
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Results First Submitted: 2018-01-24
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-24
• Results First Posted: 2019-01-25
• Last Update Submitted: 2019-01-25
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Diarrhea Duration	From onset of illness till the day of last diarrheic stool passed.	number of days with 3 or more loose or watery stools

Secondary Outcome Measures

Name	Time	Method
Illness Visits	7 days	Number of participants with illness visits
Parental Satisfaction	7 days	Parental satisfaction with treatment on a Likert scale from 0 (not satisfied) to 10 (very satisfied).
Weight Loss	7 days	Percent weight loss from baseline
Hospitalization Rate	7 days	Rate of hospitalization

Trial Locations

Locations (1)

American University of Beirut Medical Center; 🇱🇧 Beirut, Lebanon