Lactose-free Milk in Infants With Acute Diarrhea in a Developing Country
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|ClinicalTrials.gov Identifier: NCT02246010|
Recruitment Status : Terminated (Very slow recruitment rate. Only 6 infants were recruited over 2 years.)
First Posted : September 22, 2014
Results First Posted : January 25, 2019
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Gastroenteritis||Dietary Supplement: Lactose- free milk||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||July 1, 2015|
|Actual Primary Completion Date :||June 30, 2017|
|Actual Study Completion Date :||June 30, 2017|
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.
- Diarrhea Duration [ Time Frame: From onset of illness till the day of last diarrheic stool passed. ]number of days with 3 or more loose or watery stools
- Weight Loss [ Time Frame: 7 days ]Percent weight loss from baseline
- Illness Visits [ Time Frame: 7 days ]Number of participants with illness visits
- Hospitalization Rate [ Time Frame: 7 days ]Rate of hospitalization
- Parental Satisfaction [ Time Frame: 7 days ]Parental satisfaction with treatment on a Likert scale from 0 (not satisfied) to 10 (very satisfied).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246010
|American University of Beirut Medical Center|