Effect of Medium Chain Triglyceride Intake on Colonization of Preterm Infants With Candida

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.

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Key information

Conditions

Candida Infection Bacterial Infections and Mycoses Candidiasis Female Urogenital Diseases and Pregnancy Complications Infections Mycoses Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Premature Infant Urogenital Diseases

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medium-Chain Triglyceride (MCT) Oil

Drug

Infants receive 0.5 ml/oz of MCT oil to their prescribed feedings for 21 days or until hospital discharge.

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.

Sponsors and collaborators

Lead sponsor

Joseph Bliss

Other

Collaborators

Tufts University

Registry information

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2021
First posted: Aug 15, 2018
Registry last updated: Jun 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed