Effect of Medium Chain Triglyceride Intake on Colonization of Preterm Infants With Candida
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Stool Fungal Burden
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- — to 6 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
MCT Oil
This group is supplemented with MCT oil
Intervention: Medium-Chain Triglyceride (MCT) Oil (Drug)
Outcomes
Primary Outcomes
Stool Fungal Burden
Time Frame: Before supplementation, 1 week after supplementation begins, 3 weeks (at conclusion of supplementation)
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Joseph Bliss
Associate Professor of Pediatrics
Women and Infants Hospital of Rhode Island