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

March 10, 2022 updated by: Joseph Bliss
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women & Infants Hospital of Rhode Island

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
This group receives no feeding supplement.
Experimental: MCT Oil
This group is supplemented with MCT oil
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before supplementation, 1 week after supplementation begins, 3 weeks (at conclusion of supplementation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joseph Bliss

Collaborators

Tufts University

Investigators

  • Principal Investigator: Joseph M Bliss, MD, PhD, Women and Infants Hospital of Rhode Island

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2014

Primary Completion (Actual)

November 29, 2017

Study Completion (Actual)

November 2, 2021

Study Registration Dates

First Submitted

July 25, 2018

First Submitted That Met QC Criteria

August 9, 2018

First Posted (Actual)

August 15, 2018

Study Record Updates

Last Update Posted (Actual)

June 14, 2022

Last Update Submitted That Met QC Criteria

March 10, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WIH 13-0088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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