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NCT03630770 Clinical Trial

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

Premature Infant Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03630770
Other study ID # WIH 13-0088
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date June 5, 2014
Est. completion date November 2, 2021

Study information
Verified date March 2022
Source Women and Infants Hospital of Rhode Island
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date November 2, 2021
Est. primary completion date November 29, 2017
Accepts healthy volunteers No
Gender All
Age group N/A to 6 Months
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Women & Infants Hospital of Rhode Island Providence Rhode Island

Sponsors (2)
Lead Sponsor Collaborator
Joseph Bliss Tufts University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 Colonizat — View Citation

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). pii: e00020-15. doi: 10.1128/mSphere.00020-15. eCollection 2016 Jan-Feb. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Stool Fungal Burden 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)
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