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

NCT03630770 | Completed Phase 1 Results FDA Drug

• 1 other identifier: WIH 13-0088
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Candida Infection; Premature Infant

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Control

NO INTERVENTION

This group receives no feeding supplement.

MCT Oil

EXPERIMENTAL

This group is supplemented with MCT oil

Drug: Medium-Chain Triglyceride (MCT) Oil

Interventions

Medium-Chain Triglyceride (MCT) Oil DRUG

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

MCT Oil

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Prior exposure to antifungal drugs

Sponsors & Collaborators

• Joseph Bliss: lead
• Tufts University: collaborator

Study Sites (1)

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

Related Publications (2)

• 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.

  PMID: 27303684 BACKGROUND

• 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.

  PMID: 29596218 RESULT

MeSH Terms

Conditions

Candidiasis; Premature Birth

Interventions

Oils

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Lipids

Results Point of Contact

• Title: Dr. Joseph Bliss
• Organization: Women & Infants Hospital

jbliss@wihri.org

4012741100

Study Officials

• Joseph M Bliss, MD, PhD

  Women and Infants Hospital of Rhode Island

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: August 15, 2018
• Study Start: June 5, 2014
• Primary Completion: November 29, 2017
• Study Completion: November 2, 2021
• Last Updated: June 14, 2022
• Results First Posted: June 14, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)