Back to resultsEffect of Medium Chain Triglyceride Intake on Colonization of Preterm Infants With Candida
Primary Purpose
Candida Infection, Premature Infant
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Medium-Chain Triglyceride (MCT) Oil
Sponsored by
About this trial
This is an interventional prevention trial for Candida Infection
Eligibility 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
Sites / Locations
- Women & Infants Hospital of Rhode Island
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
MCT Oil
Arm Description
This group receives no feeding supplement.
This group is supplemented with MCT oil
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03630770
First Posted
July 25, 2018
Last Updated
March 10, 2022
Sponsor
Joseph Bliss
Collaborators
Tufts University
1. Study Identification
Unique Protocol Identification Number
NCT03630770
Brief Title
Effect of Medium Chain Triglyceride Intake on Colonization of Preterm Infants With Candida
Official Title
Effect of Medium Chain Triglyceride Intake on Colonization of Preterm Infants With Candida
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 5, 2014 (Actual)
Primary Completion Date
November 29, 2017 (Actual)
Study Completion Date
November 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joseph Bliss
Collaborators
Tufts University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candida Infection, Premature Infant
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
This group receives no feeding supplement.
Arm Title
MCT Oil
Arm Type
Experimental
Arm Description
This group is supplemented with MCT oil
Intervention Type
Drug
Intervention Name(s)
Medium-Chain Triglyceride (MCT) Oil
Intervention Description
Infants receive 0.5 ml/oz of MCT oil to their prescribed feedings for 21 days or until hospital discharge.
Primary Outcome Measure Information:
Title
Stool Fungal Burden
Description
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.
Time Frame
Before supplementation, 1 week after supplementation begins, 3 weeks (at conclusion of supplementation)
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph M Bliss, MD, PhD
Organizational Affiliation
Women and Infants Hospital of Rhode Island
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women & Infants Hospital of Rhode Island
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27303684
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):e00020-15. doi: 10.1128/mSphere.00020-15. eCollection 2016 Jan-Feb.
Results Reference
background
PubMed Identifier
29596218
Citation
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.
Results Reference
result
Learn more about this trial
Effect of Medium Chain Triglyceride Intake on Colonization of Preterm Infants With Candida
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