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| Name | Class |
|---|---|
| Prolacta Bioscience | INDUSTRY |
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The investigators hypothesize that children receiving human milk will maintain a greater diversity of helpful bacteria in their gut and have lower levels of inflammatory proteins in the blood compared with children not receiving human milk.
The investigators hypothesize that the gut microbiota during bone marrow transplant could be influenced by administration of enteral donor breast milk. This study will attempt to address this hypothesis, by feeding donor breast milk to young children undergoing transplant, and serially comparing the gut microbiota in children receiving human milk, with those receiving conventional feeding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enteral Donor Breastmilk | Experimental |
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| Control | No Intervention | • Children randomized to the control arm will receive standard enteral or parenteral nutrition per standard clinical practice, supervised by a registered dietician. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breastmilk | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of lactobacillales | Bar chart to indicate percentage of lactobacillales in stool samples. | 21 days after transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Pro-inflammatory cytokine level | Mean fold increase above baseline for the cytokine will be calculated and compared to control. Value will be tested for statistical significance using the Wilcoxon Rank Sum test. | weekly during study course; up to approximately one year |
| Incidence of bacteremia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stella Davies, MB.BS, PhD, MRCP | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
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Frequency of bacterial sepsis to be compared against controls. |
| though day 14 post transplant |
| Incidence of graft versus host disease (GVHD) | Frequency of GVHD will be compared to controls. | through study course; approximately one year |