Lactose-free Milk in Infants With Acute Diarrhea in a Developing Country
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 Disease | Intervention/Treatment | Phase |
---|---|---|
|
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
Arms and Interventions
Arm | Intervention/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
- 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
- Weight Loss [7 days]
Percent weight loss from baseline
- Illness Visits [7 days]
Number of participants with illness visits
- Hospitalization Rate [7 days]
Rate of hospitalization
- Parental Satisfaction [7 days]
Parental satisfaction with treatment on a Likert scale from 0 (not satisfied) to 10 (very satisfied).
Eligibility Criteria
Criteria
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
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | American University of Beirut Medical Center | Beirut | Lebanon |
Sponsors and Collaborators
- American University of Beirut Medical Center
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- PED.MN.09
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Lactose-free Milk | Regular Infant Milk |
---|---|---|
Arm/Group Description | Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days. Lactose- free milk: Lactose- free milk | Regular infant milk formula and anti-diarrheic diet for 7 days. |
Period Title: Overall Study | ||
STARTED | 4 | 2 |
COMPLETED | 4 | 2 |
NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Lactose-free Milk | Regular Infant Milk | Total |
---|---|---|---|
Arm/Group Description | Lactose- 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 Participants | 4 | 2 | 6 |
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
Title | Diarrhea Duration |
---|---|
Description | 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. |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Lactose-free Milk | Regular Infant Milk |
---|---|---|
Arm/Group Description | Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days. Lactose- free milk: Lactose- free milk | Regular infant milk formula and anti-diarrheic diet for 7 days. |
Measure Participants | 4 | 2 |
Mean (Standard Deviation) [Days] |
8.7
(2.2)
|
8.5
(2.1)
|
Title | Weight Loss |
---|---|
Description | Percent weight loss from baseline |
Time Frame | 7 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Lactose-free Milk | Regular Infant Milk |
---|---|---|
Arm/Group Description | Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days. Lactose- free milk: Lactose- free milk | Regular infant milk formula and anti-diarrheic diet for 7 days. |
Measure Participants | 4 | 2 |
Mean (Standard Deviation) [percent of body weight in kilogram] |
8.6
(0.2)
|
2.5
(0.1)
|
Title | Illness Visits |
---|---|
Description | Number of participants with illness visits |
Time Frame | 7 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Lactose-free Milk | Regular Infant Milk |
---|---|---|
Arm/Group Description | Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days. Lactose- free milk: Lactose- free milk | Regular infant milk formula and anti-diarrheic diet for 7 days. |
Measure Participants | 4 | 2 |
Count of Participants [Participants] |
3
75%
|
1
50%
|
Title | Hospitalization Rate |
---|---|
Description | Rate of hospitalization |
Time Frame | 7 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Lactose-free Milk | Regular Infant Milk |
---|---|---|
Arm/Group Description | Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days. Lactose- free milk: Lactose- free milk | Regular infant milk formula and anti-diarrheic diet for 7 days. |
Measure Participants | 4 | 2 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
Title | Parental Satisfaction |
---|---|
Description | Parental satisfaction with treatment on a Likert scale from 0 (not satisfied) to 10 (very satisfied). |
Time Frame | 7 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Lactose-free Milk | Regular Infant Milk |
---|---|---|
Arm/Group Description | Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days. Lactose- free milk: Lactose- free milk | Regular infant milk formula and anti-diarrheic diet for 7 days. |
Measure Participants | 4 | 2 |
Mean (Standard Deviation) [units on a scale] |
7.7
(0.6)
|
9.5
(0.7)
|
Adverse Events
Time Frame | Within 7 days from enrollment. | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Lactose-free Milk | Regular Infant Milk | ||
Arm/Group Description | Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days. Lactose- free milk: Lactose- free milk | Regular infant milk formula and anti-diarrheic diet for 7 days. | ||
All Cause Mortality |
||||
Lactose-free Milk | Regular Infant Milk | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/4 (0%) | 0/2 (0%) | ||
Serious Adverse Events |
||||
Lactose-free Milk | Regular Infant Milk | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/4 (0%) | 0/2 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Lactose-free Milk | Regular Infant Milk | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/4 (0%) | 0/2 (0%) |
Limitations/Caveats
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/Title | Dr. Mona Nabulsi |
---|---|
Organization | American University of Beirut |
Phone | 9611350000 ext 5523 |
mn04@aub.edu.lb |
- PED.MN.09