Trial Outcomes & Findings for Effect of Medium Chain Triglyceride Intake on Colonization of Preterm Infants With Candida (NCT NCT03630770)
NCT ID: NCT03630770
Last Updated: 2022-06-14
Results Overview
Change in colony-forming units (cfu) of Candida per gram of stool. Data table reflects total number of stool samples collected from subjects in each group that were included in the analysis.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Before supplementation, 1 week after supplementation begins, 3 weeks (at conclusion of supplementation)
Results posted on
2022-06-14
Participant Flow
Participant milestones
| Measure |
Control
This group receives no feeding supplement.
|
MCT Oil
This group is supplemented with MCT oil
Medium-Chain Triglyceride (MCT) Oil: Infants receive 0.5 ml/oz of MCT oil to their prescribed feedings for 21 days or until hospital discharge.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
8
|
|
Overall Study
COMPLETED
|
4
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control
n=4 Participants
This group receives no feeding supplement.
|
MCT Oil
n=8 Participants
This group is supplemented with MCT oil
Medium-Chain Triglyceride (MCT) Oil: Infants receive 0.5 ml/oz of MCT oil to their prescribed feedings for 21 days or until hospital discharge.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.8 weeks gestation
n=4 Participants
|
25.5 weeks gestation
n=8 Participants
|
26.7 weeks gestation
n=12 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=4 Participants
|
3 Participants
n=8 Participants
|
7 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=4 Participants
|
5 Participants
n=8 Participants
|
5 Participants
n=12 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Maternal age
|
29 years
STANDARD_DEVIATION 9 • n=4 Participants
|
30 years
STANDARD_DEVIATION 10 • n=8 Participants
|
29 years
STANDARD_DEVIATION 10 • n=12 Participants
|
|
Cesarean delivery
|
3 Participants
n=4 Participants
|
6 Participants
n=8 Participants
|
9 Participants
n=12 Participants
|
|
Prenatal steroids
|
3 Participants
n=4 Participants
|
6 Participants
n=8 Participants
|
9 Participants
n=12 Participants
|
|
Birth weight
|
1032 grams
n=4 Participants
|
745 grams
n=8 Participants
|
889 grams
n=12 Participants
|
|
Total parenteral nutrition duration
|
15.5 days
n=4 Participants
|
16 days
n=8 Participants
|
15.8 days
n=12 Participants
|
|
Umbilical line duration
|
4.5 days
n=4 Participants
|
7.6 days
n=8 Participants
|
6.1 days
n=12 Participants
|
|
Peripherally inserted central catheter duration
|
9.7 days
n=4 Participants
|
7.6 days
n=8 Participants
|
8.7 days
n=12 Participants
|
|
Breast milk feeds
|
3 Participants
n=4 Participants
|
5 Participants
n=8 Participants
|
8 Participants
n=12 Participants
|
|
Formula feeds
|
1 Participants
n=4 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=12 Participants
|
|
Postnatal steroids
|
0 Participants
n=4 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=12 Participants
|
|
Antacid treatment
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=12 Participants
|
|
Antibiotic duration
|
4.5 days
n=4 Participants
|
8.1 days
n=8 Participants
|
6.3 days
n=12 Participants
|
PRIMARY outcome
Timeframe: Before supplementation, 1 week after supplementation begins, 3 weeks (at conclusion of supplementation)Population: Candida colony counts per gram of stool in each sample
Change in colony-forming units (cfu) of Candida per gram of stool. Data table reflects total number of stool samples collected from subjects in each group that were included in the analysis.
Outcome measures
| Measure |
Control
n=50 stool samples
This group receives no feeding supplement.
|
MCT Oil
n=130 stool samples
This group is supplemented with MCT oil
Medium-Chain Triglyceride (MCT) Oil: Infants receive 0.5 ml/oz of MCT oil to their prescribed feedings for 21 days or until hospital discharge.
|
|---|---|---|
|
Stool Fungal Burden
During supplementation
|
1671 cfu per gram
Interval 42.5 to 108500.0
|
622.5 cfu per gram
Interval 43.0 to 3925.0
|
|
Stool Fungal Burden
Before supplementation
|
500 cfu per gram
Interval 26.0 to 21000.0
|
55000 cfu per gram
Interval 3885.0 to 86000.0
|
|
Stool Fungal Burden
After supplementation
|
1744 cfu per gram
Interval 23.0 to 26330.0
|
2364 cfu per gram
Interval 800.0 to 7000.0
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MCT Oil
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