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This study evaluates the effects of either Pediasure or Nourish formulas on the gastrointestinal microbiome in critically-ill children. Patients will be randomized to received either Pediasure or Nourish.
The gastrointestinal microbiome has been shown to be altered in critically-ill children such that there is a larger shift toward pathogenic bacteria. Previous studies have shown that probiotics, fecal transplants, antibiotic decontamination, and dietary interventions can shift the gastrointestinal microbiome toward a metabolically favorable microbiome profile and be associated with improvements in disease burden.
This study will randomize critically-ill children who are stable enough for enteral tube feedings to receive either Pediasure or Nourish. Pediasure is a commercially-made formula that is used commonly in pediatric patients. Nourish is an organic, whole-food formula with a high fiber content. High-fiber diets have been correlated with metabolically favorable microbiome profiles. This study will look at the microbiome before and after initiation of enteral tube feedings to determine if either formula is associated with a shift in the microbiome toward a favorable profile.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediasure | Active Comparator | Patients assigned to this arm will receive Pediasure |
|
| Nourish | Active Comparator | Patients assigned to this arm will receive Nourish |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nourish | Other | The effects of Nourish on the gastrointestinal microbiome will be compared to the the effects of Pediasure on the gastrointestinal microbiome |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes to the gastrointestinal microbiome | Fecal samples will be collected for bacterial 16s rRNA gene sequencing and analysis | Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings |
| Changes to the gastrointestinal microbiome | Salivary samples will be collected for bacterial 16s rRNA gene sequencing and analysis | Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of short-chain fatty acids | Fecal samples will be analyzed by gas chromatography | Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raj Aneja, MD | University of Pittsburgh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D064806 | Dysbiosis |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007945 | Leukemia, Lymphoid |
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Critically-ill children who are medically stable and ready for enteral tube feeds will be randomized to receive either Pediasure or Nourish. Nutritional needs will be calculated per previously established standards at our institution and performed in conjunction with trained dieticians and nutritionists.
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| Pediasure | Other | The effects of Nourish on the gastrointestinal microbiome will be compared to the the effects of Pediasure on the gastrointestinal microbiome |
|
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |