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| Name | Class |
|---|---|
| Tufts University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | This group receives no feeding supplement. | |
| MCT Oil | Experimental | This group is supplemented with MCT oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph M Bliss, MD, PhD | Women and Infants Hospital of Rhode Island | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women & Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27303684 | Background | 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. | |
| 29596218 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | This group receives no feeding supplement. |
| FG001 | MCT Oil | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | This group receives no feeding supplement. |
| BG001 | MCT Oil | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Candida colony counts per gram of stool in each sample | Posted | Median | Inter-Quartile Range | cfu per gram | Before supplementation, 1 week after supplementation begins, 3 weeks (at conclusion of supplementation) | stool samples | stool samples |
|
Through duration of hospitalization, an average of 3 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | This group receives no feeding supplement. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joseph Bliss | Women & Infants Hospital | 4012741100 | jbliss@wihri.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 12, 2018 | Aug 9, 2018 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D007752 | Obstetric Labor, Premature |
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| ID | Term |
|---|---|
| D009821 | Oils |
| ID | Term |
|---|---|
| D008055 | Lipids |
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| BG002 | Total | Total of all reporting groups |
| weeks gestation |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Maternal age | Mean | Standard Deviation | years |
|
| Cesarean delivery | Count of Participants | Participants |
|
| Prenatal steroids | Count of Participants | Participants |
|
| Birth weight | Mean | Full Range | grams |
|
| Total parenteral nutrition duration | Mean | Full Range | days |
|
| Umbilical line duration | Mean | Full Range | days |
|
| Peripherally inserted central catheter duration | Mean | Full Range | days |
|
| Breast milk feeds | Count of Participants | Participants |
|
| Formula feeds | Count of Participants | Participants |
|
| Postnatal steroids | Count of Participants | Participants |
|
| Antacid treatment | Count of Participants | Participants |
|
| Antibiotic duration | Mean | Full Range | days |
|
|
|
|
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | MCT Oil | 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. | 0 | 8 | 0 | 8 | 0 | 8 |
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| D007744 |
| Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
|
|