Candida InfectionPhase 1NCT03630770
Effect of Medium Chain Triglyceride Intake on Colonization of Preterm Infants With Candida
A Phase 1 study testing Medium-Chain Triglyceride (MCT) Oil in people with Candida Infection and Premature Infant, run by Joseph Bliss at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Candida Infection, Premature Infant
- What is being tested?
- Medium-Chain Triglyceride (MCT) Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2014to 2 Nov 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Prior exposure to antifungal drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
About this study
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
- Being tested
- Medium-Chain Triglyceride (MCT) Oil
- Medical subject headings
- Candidiasis, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medium-Chain Triglyceride (MCT) OilDrug
Infants receive 0.5 ml/oz of MCT oil to their prescribed feedings for 21 days or until hospital discharge.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This group receives no feeding supplement. |
| MCT Oil | Experimental | This group is supplemented with MCT oil Receives: Drug: Medium-Chain Triglyceride (MCT) Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before supplementation, 1 week after supplementation begins, 3 weeks (at conclusion of supplementation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start5 Jun 2014
- Primary completion29 Nov 2017
- Study completion2 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Candida InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph Bliss
- Sponsor type
- University, hospital or other
- Collaborators
- Tufts University
- Responsible party
- Sponsor-investigator, Joseph Bliss, Women and Infants Hospital of Rhode Island
- Investigators
- Joseph M Bliss, MD, PhD, Principal investigator, Women and Infants Hospital of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630770
- Sponsor's protocol ID
- WIH 13-0088
- Status last verified
- Mar 2022
- First submitted
- 25 Jul 2018
- Last updated
- 14 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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):e00020-15. doi: 10.1128/mSphere.00020-15. eCollection 2016 Jan-Feb.
PubMed 27303684Arsenault 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.
PubMed 29596218
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Medium Chain Triglyceride Intake on Colonization of Preterm Infants With Candida
- ClinicalTrials.gov ID
- NCT03630770
- Acronym / sponsor ID
- WIH 13-0088
- Conditions
- Candida Infection, Premature Infant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Joseph BlissUniversity, hospital or other
- Collaborators
- Tufts University
- Study start
- 5 Jun 2014 (actual)
- Primary completion
- 29 Nov 2017 (actual)
- Study completion
- 2 Nov 2021 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Posted 14 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This group receives no feeding supplement. |
| MCT Oil | Experimental | Drug: Medium-Chain Triglyceride (MCT) OilThis group is supplemented with MCT oil |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Prior exposure to antifungal drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medium-Chain Triglyceride (MCT) OilInfants receive 0.5 ml/oz of MCT oil to their prescribed feedings for 21 days or until hospital discharge. | Drug | MCT Oil |
Primary outcome
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. Data table reflects total number of stool samples collected from subjects in each group that were included in the analysis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27303684Gunsalus 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 publication: PubMed 29596218Arsenault 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph M Bliss, MD, PhD principal investigator
Women and Infants Hospital of Rhode Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Medium-Chain Triglyceride (MCT) Oil in people with Candida Infection and Premature Infant, run by Joseph Bliss at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool Fungal Burden (time frame: Before supplementation, 1 week after supplementation begins, 3 weeks (at conclusion of supplementation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03630770, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.