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

Acute Gastroenteritis Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02246010
• Other study ID #: PED.MN.09
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2015
• Est. completion date: June 30, 2017

Study information

• Verified date: January 2019
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 18 Months

Eligibility

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

Related Conditions & MeSH terms

• Acute Gastroenteritis
• Diarrhea
• Gastroenteritis

Intervention

Dietary Supplement:
• Lactose- free milk
Lactose- free milk

Locations

Country	Name	City	State
Lebanon	American University of Beirut Medical Center	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diarrhea Duration	number of days with 3 or more loose or watery stools	From onset of illness till the day of last diarrheic stool passed.
Secondary	Weight Loss	Percent weight loss from baseline	7 days
Secondary	Illness Visits	Number of participants with illness visits	7 days
Secondary	Hospitalization Rate	Rate of hospitalization	7 days
Secondary	Parental Satisfaction	Parental satisfaction with treatment on a Likert scale from 0 (not satisfied) to 10 (very satisfied).	7 days