Phase 1
N=12
Effect of Medium Chain Triglyceride Intake on Colonization of Preterm Infants With Candida
Candida Infection · Premature Infant
Bottom Line
View on ClinicalTrials.gov: NCT03630770 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Stool Fungal Burden — 500; 55000; 1671; 622.5 cfu per gram — p=0.9
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Medium-Chain Triglyceride (MCT) Oil (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Joseph Bliss
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stool Fungal Burden |
500; 55000; 1671; 622.5; 1744; 2364 | 0.9 |
Summary
This study evaluates whether adding a dietary supplement similar to coconut oil (MCT oil) to feedings in premature infants will reduce the amount of yeast (Candida) detectable in their stool. Infants who have Candida in their stool are eligible to participate. Half of the enrolled infants will have additional MCT oil added to their feedings and half will not.
Eligibility Criteria
Inclusion Criteria
- Premature infant admitted to the Neonatal Intensive Care Unit at Women & Infants Hospital
- Receiving full enteral feeds of either preterm or transitional formula or fortified breast milk
- Anticipated to have a minimum stay of two weeks
Exclusion Criteria
- Prior exposure to antifungal drugs
Data sourced from ClinicalTrials.gov (NCT03630770). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.