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

Does Intake of Lactose-free Milk in Infants With Acute Gastroenteritis in a Developing Country Shorten the Duration of Diarrhea? A Randomized Clinical Trial.

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02246010
Enrollment
6
Registered
2014-09-22
Start date
2015-07-01
Completion date
2017-06-30
Last updated
2019-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Gastroenteritis

Keywords

diarrhea, developing world, lactose-free diet, Clinical trial

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.

Interventions

DIETARY_SUPPLEMENTLactose- free milk

Lactose- free milk

Sponsors

American University of Beirut Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Months to 18 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Diarrhea DurationFrom onset of illness till the day of last diarrheic stool passed.number of days with 3 or more loose or watery stools

Secondary

MeasureTime frameDescription
Weight Loss7 daysPercent weight loss from baseline
Illness Visits7 daysNumber of participants with illness visits
Hospitalization Rate7 daysRate of hospitalization
Parental Satisfaction7 daysParental satisfaction with treatment on a Likert scale from 0 (not satisfied) to 10 (very satisfied).

Countries

Lebanon

Participant flow

Participants by arm

ArmCount
Lactose-free Milk
Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days.
4
Regular Infant Milk
Regular infant milk formula and anti-diarrheic diet for 7 days.
2
Total6

Baseline characteristics

CharacteristicLactose-free MilkRegular Infant MilkTotal
Age, Customized
Equal or more than 6 months
3 Participants2 Participants5 Participants
Age, Customized
Less than 6 months
1 Participants0 Participants1 Participants
Diarrhea duration4.2 Days
STANDARD_DEVIATION 2.2
3.5 Days
STANDARD_DEVIATION 0.7
4.0 Days
STANDARD_DEVIATION 1.7
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
4 Participants2 Participants6 Participants
Sex: Female, Male
Female
2 Participants1 Participants3 Participants
Sex: Female, Male
Male
2 Participants1 Participants3 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 40 / 2
other
Total, other adverse events
0 / 40 / 2
serious
Total, serious adverse events
0 / 40 / 2

Outcome results

Primary

Diarrhea Duration

number of days with 3 or more loose or watery stools

Time frame: From onset of illness till the day of last diarrheic stool passed.

ArmMeasureValue (MEAN)Dispersion
Lactose-free MilkDiarrhea Duration8.7 DaysStandard Deviation 2.2
Regular Infant MilkDiarrhea Duration8.5 DaysStandard Deviation 2.1
Secondary

Hospitalization Rate

Rate of hospitalization

Time frame: 7 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Lactose-free MilkHospitalization Rate0 Participants
Regular Infant MilkHospitalization Rate0 Participants
Secondary

Illness Visits

Number of participants with illness visits

Time frame: 7 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Lactose-free MilkIllness Visits3 Participants
Regular Infant MilkIllness Visits1 Participants
Secondary

Parental Satisfaction

Parental satisfaction with treatment on a Likert scale from 0 (not satisfied) to 10 (very satisfied).

Time frame: 7 days

ArmMeasureValue (MEAN)Dispersion
Lactose-free MilkParental Satisfaction7.7 units on a scaleStandard Deviation 0.6
Regular Infant MilkParental Satisfaction9.5 units on a scaleStandard Deviation 0.7
Secondary

Weight Loss

Percent weight loss from baseline

Time frame: 7 days

ArmMeasureValue (MEAN)Dispersion
Lactose-free MilkWeight Loss8.6 percent of body weight in kilogramStandard Deviation 0.2
Regular Infant MilkWeight Loss2.5 percent of body weight in kilogramStandard Deviation 0.1

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026