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

• Sponsor: Joseph Bliss (Other)
• Overall Status: Completed
• CT.gov ID: NCT03630770
• Collaborator: Tufts University (Other)
• Enrollment: 12
• Location: 1
• Arms: 2
• Actual Duration (Months): 88.9
• Patients Per Site Per Month: 0.1

Study Details

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.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 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: Jun 5, 2014
• Actual Primary Completion Date: Nov 29, 2017
• Actual Study Completion Date: Nov 2, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Stool Fungal Burden [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. Data table reflects total number of stool samples collected from subjects in each group that were included in the analysis.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 6 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Women & Infants Hospital of Rhode Island	Providence	Rhode Island	United States	02905

Sponsors and Collaborators

• Joseph Bliss
• Tufts University

Investigators

• Principal Investigator: Joseph M Bliss, MD, PhD, Women and Infants Hospital of Rhode Island

Study Documents (Full-Text)

• Study Protocol - Jan 12, 2018

More Information

Publications

• 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.

• 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: Aug 15, 2018
• Last Update Posted: Jun 14, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Candidiasis

Study Results

Participant Flow

Arm/Group Title	Control	MCT Oil
Arm/Group Description	This group receives no feeding supplement.	This group is supplemented with MCT oil 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.
Period Title: Overall Study
STARTED	4	8
COMPLETED	4	8
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Control	MCT Oil	Total
Arm/Group Description	This group receives no feeding supplement.	This group is supplemented with MCT oil 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.	Total of all reporting groups
Overall Participants	4	8	12
Age (weeks gestation) [Mean (Full Range) ]
Mean (Full Range) [weeks gestation]	27.8	25.5	26.7
Sex: Female, Male (Count of Participants)
Female	4 100%	3 37.5%	7 58.3%
Male	0 0%	5 62.5%	5 41.7%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Maternal age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29 (9)	30 (10)	29 (10)
Cesarean delivery (Count of Participants)
Count of Participants [Participants]	3 75%	6 75%	9 75%
Prenatal steroids (Count of Participants)
Count of Participants [Participants]	3 75%	6 75%	9 75%
Birth weight (grams) [Mean (Full Range) ]
Mean (Full Range) [grams]	1032	745	889
Total parenteral nutrition duration (days) [Mean (Full Range) ]
Mean (Full Range) [days]	15.5	16	15.8
Umbilical line duration (days) [Mean (Full Range) ]
Mean (Full Range) [days]	4.5	7.6	6.1
Peripherally inserted central catheter duration (days) [Mean (Full Range) ]
Mean (Full Range) [days]	9.7	7.6	8.7
Breast milk feeds (Count of Participants)
Count of Participants [Participants]	3 75%	5 62.5%	8 66.7%
Formula feeds (Count of Participants)
Count of Participants [Participants]	1 25%	3 37.5%	4 33.3%
Postnatal steroids (Count of Participants)
Count of Participants [Participants]	0 0%	3 37.5%	3 25%
Antacid treatment (Count of Participants)
Count of Participants [Participants]	0 0%	0 0%	0 0%
Antibiotic duration (days) [Mean (Full Range) ]
Mean (Full Range) [days]	4.5	8.1	6.3

Outcome Measures

1. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

Candida colony counts per gram of stool in each sample

Arm/Group Title	Control	MCT Oil
Arm/Group Description	This group receives no feeding supplement.	This group is supplemented with MCT oil 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.
Measure Participants	4	8
Measure stool samples	50	130
Before supplementation	500	55000
During supplementation	1671	622.5
After supplementation	1744	2364

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control
	Comments	Stool fungal counts (cfu/g) were compared between groups using negative binomial regression within time period (before, during, after). Rate ratio was calculated to reflect the direction and magnitude of change in stool colony counts between time periods (before v. during supplementation) for the control group.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9
	Comments	p-values underwent generalized estimating equations adjustment for multiple measures per individuals within time.
	Method	Negative binomial regression
	Comments
Method of Estimation	Estimation Parameter	Rate Ratio
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.55 to 1.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Control
	Comments	Stool fungal counts (cfu/g) were compared between groups using negative binomial regression within time period (before, during, after). Rate ratio was calculated to reflect the direction and magnitude of change in stool colony counts between time periods (during v. after supplementation) for the control group.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-values underwent generalized estimating equations adjustment for multiple measures per individuals within time.
	Method	Negative binomial regression
	Comments
Method of Estimation	Estimation Parameter	Rate Ratio
	Estimated Value	8.1
	Confidence Interval	(2-Sided) 95%; 2.6 to 25
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	MCT Oil
	Comments	Stool fungal counts (cfu/g) were compared between groups using negative binomial regression within time period (before, during, after). Rate ratio was calculated to reflect the direction and magnitude of change in stool colony counts between time periods (before v. during supplementation) for the MCT group.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments	p-values underwent generalized estimating equations adjustment for multiple measures per individuals within time.
	Method	Negative binomial regression
	Comments
Method of Estimation	Estimation Parameter	Rate Ratio
	Estimated Value	0.15
	Confidence Interval	(2-Sided) 95%; 0.03 to 0.75
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	MCT Oil
	Comments	Stool fungal counts (cfu/g) were compared between groups using negative binomial regression within time period (before, during, after). Rate ratio was calculated to reflect the direction and magnitude of change in stool colony counts between time periods (during v. after supplementation) for the MCT group.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	p-values underwent generalized estimating equations adjustment for multiple measures per individuals within time.
	Method	Negative binomial regression
	Comments
Method of Estimation	Estimation Parameter	Rate Ratio
	Estimated Value	61
	Confidence Interval	(2-Sided) 95%; 6.9 to 533
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Through duration of hospitalization, an average of 3 weeks
Arm/Group Title	Control		MCT Oil
Arm/Group Description	This group receives no feeding supplement.		This group is supplemented with MCT oil 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.
All Cause Mortality
	Control		MCT Oil
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/8 (0%)
Serious Adverse Events
	Control		MCT Oil
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	Control		MCT Oil
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/8 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.