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

Sponsor
American University of Beirut Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT02246010
Collaborator
(none)
6
Enrollment
1
Location
2
Arms
24
Actual Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Dietary Supplement: Lactose- free milk
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Jul 1, 2015
Actual Primary Completion Date :
Jun 30, 2017
Actual Study Completion Date :
Jun 30, 2017

Arms and Interventions

ArmIntervention/Treatment
Experimental: Lactose-free milk

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

Dietary Supplement: Lactose- free milk
Lactose- free milk

No Intervention: Regular infant milk

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Weight Loss [7 days]

    Percent weight loss from baseline

  2. Illness Visits [7 days]

    Number of participants with illness visits

  3. Hospitalization Rate [7 days]

    Rate of hospitalization

  4. Parental Satisfaction [7 days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Months to 18 Months
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1American University of Beirut Medical CenterBeirutLebanon

Sponsors and Collaborators

  • American University of Beirut Medical Center

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Mona Nabulsi, Professor of Clinical Pediatrics, American University of Beirut Medical Center
ClinicalTrials.gov Identifier:
NCT02246010
Other Study ID Numbers:
  • PED.MN.09
First Posted:
Sep 22, 2014
Last Update Posted:
Feb 15, 2019
Last Verified:
Jan 1, 2019
Keywords provided by Mona Nabulsi, Professor of Clinical Pediatrics, American University of Beirut Medical Center
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleLactose-free MilkRegular Infant Milk
Arm/Group DescriptionLactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days. Lactose- free milk: Lactose- free milkRegular infant milk formula and anti-diarrheic diet for 7 days.
Period Title: Overall Study
STARTED42
COMPLETED42
NOT COMPLETED00

Baseline Characteristics

Arm/Group TitleLactose-free MilkRegular Infant MilkTotal
Arm/Group DescriptionLactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days.Regular infant milk formula and anti-diarrheic diet for 7 days.Total of all reporting groups
Overall Participants426
Age, Customized (Count of Participants)
Less than 6 months
1
25%
0
0%
1
16.7%
Equal or more than 6 months
3
75%
2
100%
5
83.3%
Sex: Female, Male (Count of Participants)
Female
2
50%
1
50%
3
50%
Male
2
50%
1
50%
3
50%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
0
0%
0
0%
0
0%
White
4
100%
2
100%
6
100%
More than one race
0
0%
0
0%
0
0%
Unknown or Not Reported
0
0%
0
0%
0
0%
Diarrhea duration (Days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Days]
4.2
(2.2)
3.5
(0.7)
4.0
(1.7)

Outcome Measures

1. Primary Outcome
TitleDiarrhea Duration
Descriptionnumber of days with 3 or more loose or watery stools
Time FrameFrom onset of illness till the day of last diarrheic stool passed.

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleLactose-free MilkRegular Infant Milk
Arm/Group DescriptionLactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days. Lactose- free milk: Lactose- free milkRegular infant milk formula and anti-diarrheic diet for 7 days.
Measure Participants42
Mean (Standard Deviation) [Days]
8.7
(2.2)
8.5
(2.1)
2. Secondary Outcome
TitleWeight Loss
DescriptionPercent weight loss from baseline
Time Frame7 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleLactose-free MilkRegular Infant Milk
Arm/Group DescriptionLactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days. Lactose- free milk: Lactose- free milkRegular infant milk formula and anti-diarrheic diet for 7 days.
Measure Participants42
Mean (Standard Deviation) [percent of body weight in kilogram]
8.6
(0.2)
2.5
(0.1)
3. Secondary Outcome
TitleIllness Visits
DescriptionNumber of participants with illness visits
Time Frame7 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleLactose-free MilkRegular Infant Milk
Arm/Group DescriptionLactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days. Lactose- free milk: Lactose- free milkRegular infant milk formula and anti-diarrheic diet for 7 days.
Measure Participants42
Count of Participants [Participants]
3
75%
1
50%
4. Secondary Outcome
TitleHospitalization Rate
DescriptionRate of hospitalization
Time Frame7 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleLactose-free MilkRegular Infant Milk
Arm/Group DescriptionLactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days. Lactose- free milk: Lactose- free milkRegular infant milk formula and anti-diarrheic diet for 7 days.
Measure Participants42
Count of Participants [Participants]
0
0%
0
0%
5. Secondary Outcome
TitleParental Satisfaction
DescriptionParental satisfaction with treatment on a Likert scale from 0 (not satisfied) to 10 (very satisfied).
Time Frame7 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleLactose-free MilkRegular Infant Milk
Arm/Group DescriptionLactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days. Lactose- free milk: Lactose- free milkRegular infant milk formula and anti-diarrheic diet for 7 days.
Measure Participants42
Mean (Standard Deviation) [units on a scale]
7.7
(0.6)
9.5
(0.7)

Adverse Events

Time FrameWithin 7 days from enrollment.
Adverse Event Reporting Description
Arm/Group TitleLactose-free MilkRegular Infant Milk
Arm/Group DescriptionLactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days. Lactose- free milk: Lactose- free milkRegular infant milk formula and anti-diarrheic diet for 7 days.
All Cause Mortality
Lactose-free MilkRegular Infant Milk
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/4 (0%) 0/2 (0%)
Serious Adverse Events
Lactose-free MilkRegular Infant Milk
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/4 (0%) 0/2 (0%)
Other (Not Including Serious) Adverse Events
Lactose-free MilkRegular Infant Milk
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/4 (0%) 0/2 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleDr. Mona Nabulsi
OrganizationAmerican University of Beirut
Phone9611350000 ext 5523
Emailmn04@aub.edu.lb
Responsible Party:
Mona Nabulsi, Professor of Clinical Pediatrics, American University of Beirut Medical Center
ClinicalTrials.gov Identifier:
NCT02246010
Other Study ID Numbers:
  • PED.MN.09
First Posted:
Sep 22, 2014
Last Update Posted:
Feb 15, 2019
Last Verified:
Jan 1, 2019