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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03630770
Recruitment Status : Active, not recruiting
First Posted : August 15, 2018
Last Update Posted : April 6, 2021
Sponsor:
Collaborator:
Tufts University
Information provided by (Responsible Party):
Joseph Bliss, Women and Infants Hospital of Rhode Island

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.

Condition or disease Intervention/treatment Phase
Candida Infection Premature Infant Drug: Medium-Chain Triglyceride (MCT) Oil Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Medium Chain Triglyceride Intake on Colonization of Preterm Infants With Candida
Actual Study Start Date : June 5, 2014
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03630770


Locations
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United States, Rhode Island
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Joseph Bliss
Tufts University
Investigators
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Principal Investigator: Joseph M Bliss, MD, PhD Women and Infants Hospital of Rhode Island
  Study Documents (Full-Text)

Documents provided by Joseph Bliss, Women and Infants Hospital of Rhode Island:
Study Protocol  [PDF] January 12, 2018

Publications of Results:
Other Publications:
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Responsible Party: Joseph Bliss, Associate Professor of Pediatrics, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT03630770    
Other Study ID Numbers: WIH 13-0088
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Candidiasis
Mycoses