Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Mothers' Milk Bank Northeast | OTHER |
Not provided
Not provided
Not provided
Not provided
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 micobiota in children receiving human milk, with those receiving conventional feeding.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enteral Donor Breastmilk | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breastmilk | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of lactobacillales | Bar charts to indicate types and percentage of bacteria in stool samples - will quantify the bacterial diversity using the Shannon index and bacterial chaos using the Bray-Curtis time index. | 21 days after transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of pro-inflammatory cytokines | Mean fold increase above baseline for each cytokine will be calculated and compared to controls | Weekly during study course; up to approximately one year |
| Incidence of bacteremia |
Not provided
Inclusion Criteria:
Exclusion Criteria:
- Failure to meet inclusion criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stella Davies, MBBS, 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Frequency of bacterial sepsis to be compared against controls
| through 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 |