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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
Sponsor:
Information provided by (Responsible Party):
Mona Nabulsi, American University of Beirut Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Gastroenteritis
Intervention Dietary Supplement: Lactose- free milk
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lactose-free Milk Regular Infant Milk
Hide 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
Arm/Group Title Lactose-free Milk Regular Infant Milk Total
Hide 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 Number of Baseline Participants 4 2 6
Hide Baseline Analysis Population Description
Infants between 2 months and 18 months presenting with acute diarrhea.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 2 participants 6 participants
Less than 6 months
1
  25.0%
0
   0.0%
1
  16.7%
Equal or more than 6 months
3
  75.0%
2
 100.0%
5
  83.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 2 participants 6 participants
Female
2
  50.0%
1
  50.0%
3
  50.0%
Male
2
  50.0%
1
  50.0%
3
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 2 participants 6 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
4
 100.0%
2
 100.0%
6
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Diarrhea duration   [1] 
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 4 participants 2 participants 6 participants
4.2  (2.2) 3.5  (0.7) 4.0  (1.7)
[1]
Measure Description: Number of days with diarrhea.
1.Primary Outcome
Title Diarrhea Duration
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactose-free Milk Regular Infant Milk
Hide 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.
Overall Number of Participants Analyzed 4 2
Mean (Standard Deviation)
Unit of Measure: Days
8.7  (2.2) 8.5  (2.1)
2.Secondary Outcome
Title Weight Loss
Hide Description Percent weight loss from baseline
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactose-free Milk Regular Infant Milk
Hide 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.
Overall Number of Participants Analyzed 4 2
Mean (Standard Deviation)
Unit of Measure: percent of body weight in kilogram
8.6  (0.2) 2.5  (0.1)
3.Secondary Outcome
Title Illness Visits
Hide Description Number of participants with illness visits
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactose-free Milk Regular Infant Milk
Hide 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.
Overall Number of Participants Analyzed 4 2
Measure Type: Count of Participants
Unit of Measure: Participants
3
  75.0%
1
  50.0%
4.Secondary Outcome
Title Hospitalization Rate
Hide Description Rate of hospitalization
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactose-free Milk Regular Infant Milk
Hide 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.
Overall Number of Participants Analyzed 4 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Parental Satisfaction
Hide Description Parental satisfaction with treatment on a Likert scale from 0 (not satisfied) to 10 (very satisfied).
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactose-free Milk Regular Infant Milk
Hide 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.
Overall Number of Participants Analyzed 4 2
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.7  (0.6) 9.5  (0.7)
Time Frame Within 7 days from enrollment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lactose-free Milk Regular Infant Milk
Hide 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 (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/2 (0.00%) 
Hide Serious Adverse Events
Lactose-free Milk Regular Infant Milk
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/2 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lactose-free Milk Regular Infant Milk
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/2 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Mona Nabulsi
Organization: American University of Beirut
Phone: 9611350000 ext 5523
EMail: mn04@aub.edu.lb
Layout table for additonal information
Responsible Party: Mona Nabulsi, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT02246010    
Other Study ID Numbers: PED.MN.09
First Submitted: September 18, 2014
First Posted: September 22, 2014
Results First Submitted: January 24, 2018
Results First Posted: January 25, 2019
Last Update Posted: February 15, 2019