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

NCT ID: NCT03630770

Last Updated: 2022-06-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-05

Study Completion Date

2021-11-02

Brief Summary

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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.

Detailed Description

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Conditions

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Candida Infection Premature Infant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

This group receives no feeding supplement.

Group Type NO_INTERVENTION

No interventions assigned to this group

MCT Oil

This group is supplemented with MCT oil

Group Type EXPERIMENTAL

Medium-Chain Triglyceride (MCT) Oil

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tufts University

OTHER

Sponsor Role collaborator

Joseph Bliss

OTHER

Sponsor Role lead

Responsible Party

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Joseph Bliss

Associate Professor of Pediatrics

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Joseph M Bliss, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Women and Infants Hospital of Rhode Island

Locations

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Women & Infants Hospital of Rhode Island

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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Gunsalus KT, Tornberg-Belanger SN, Matthan NR, Lichtenstein AH, Kumamoto CA. Manipulation of Host Diet To Reduce Gastrointestinal Colonization by the Opportunistic Pathogen Candida albicans. mSphere. 2015 Nov 18;1(1):e00020-15. doi: 10.1128/mSphere.00020-15. eCollection 2016 Jan-Feb.

Reference Type BACKGROUND
PMID: 27303684 (View on PubMed)

Arsenault AB, Gunsalus KTW, Laforce-Nesbitt SS, Przystac L, DeAngelis EJ, Hurley ME, Vorel ES, Tucker R, Matthan NR, Lichtenstein AH, Kumamoto CA, Bliss JM. Dietary Supplementation With Medium-Chain Triglycerides Reduces Candida Gastrointestinal Colonization in Preterm Infants. Pediatr Infect Dis J. 2019 Feb;38(2):164-168. doi: 10.1097/INF.0000000000002042.

Reference Type RESULT
PMID: 29596218 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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WIH 13-0088

Identifier Type: -

Identifier Source: org_study_id

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