Trial Outcomes & Findings for Lactose-free Milk in Infants With Acute Diarrhea in a Developing Country (NCT NCT02246010)
NCT ID: NCT02246010
Last Updated: 2019-02-15
Results Overview
number of days with 3 or more loose or watery stools
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
From onset of illness till the day of last diarrheic stool passed.
Results posted on
2019-02-15
Participant Flow
Participant milestones
| Measure |
Lactose-free Milk
Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days.
Lactose- free milk: Lactose- free milk
|
Regular Infant Milk
Regular infant milk formula and anti-diarrheic diet for 7 days.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
|
Overall Study
COMPLETED
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lactose-free Milk in Infants With Acute Diarrhea in a Developing Country
Baseline characteristics by cohort
| Measure |
Lactose-free Milk
n=4 Participants
Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days.
|
Regular Infant Milk
n=2 Participants
Regular infant milk formula and anti-diarrheic diet for 7 days.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Less than 6 months
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Customized
Equal or more than 6 months
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Diarrhea duration
|
4.2 Days
STANDARD_DEVIATION 2.2 • n=99 Participants
|
3.5 Days
STANDARD_DEVIATION 0.7 • n=107 Participants
|
4.0 Days
STANDARD_DEVIATION 1.7 • n=206 Participants
|
PRIMARY outcome
Timeframe: From onset of illness till the day of last diarrheic stool passed.number of days with 3 or more loose or watery stools
Outcome measures
| Measure |
Lactose-free Milk
n=4 Participants
Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days.
Lactose- free milk: Lactose- free milk
|
Regular Infant Milk
n=2 Participants
Regular infant milk formula and anti-diarrheic diet for 7 days.
|
|---|---|---|
|
Diarrhea Duration
|
8.7 Days
Standard Deviation 2.2
|
8.5 Days
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: 7 daysPercent weight loss from baseline
Outcome measures
| Measure |
Lactose-free Milk
n=4 Participants
Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days.
Lactose- free milk: Lactose- free milk
|
Regular Infant Milk
n=2 Participants
Regular infant milk formula and anti-diarrheic diet for 7 days.
|
|---|---|---|
|
Weight Loss
|
8.6 percent of body weight in kilogram
Standard Deviation 0.2
|
2.5 percent of body weight in kilogram
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: 7 daysNumber of participants with illness visits
Outcome measures
| Measure |
Lactose-free Milk
n=4 Participants
Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days.
Lactose- free milk: Lactose- free milk
|
Regular Infant Milk
n=2 Participants
Regular infant milk formula and anti-diarrheic diet for 7 days.
|
|---|---|---|
|
Illness Visits
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 7 daysRate of hospitalization
Outcome measures
| Measure |
Lactose-free Milk
n=4 Participants
Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days.
Lactose- free milk: Lactose- free milk
|
Regular Infant Milk
n=2 Participants
Regular infant milk formula and anti-diarrheic diet for 7 days.
|
|---|---|---|
|
Hospitalization Rate
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 7 daysParental satisfaction with treatment on a Likert scale from 0 (not satisfied) to 10 (very satisfied).
Outcome measures
| Measure |
Lactose-free Milk
n=4 Participants
Lactose- free milk formula (Similac LF®) and anti-diarrheic diet for 7 days.
Lactose- free milk: Lactose- free milk
|
Regular Infant Milk
n=2 Participants
Regular infant milk formula and anti-diarrheic diet for 7 days.
|
|---|---|---|
|
Parental Satisfaction
|
7.7 units on a scale
Standard Deviation 0.6
|
9.5 units on a scale
Standard Deviation 0.7
|
Adverse Events
Lactose-free Milk
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Regular Infant Milk
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place