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| Name | Class |
|---|---|
| Midwest Children's Health Research Institute | UNKNOWN |
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This clinical trial will evaluate the stool of infants fed one of two infant formulas, which contain different types of proteins, or breast milk to determine if different proteins have an effect on the type of bacteria that enters and lives in an infant's intestine early in life.
This clinical trial will evaluate the stool of infants fed one of two infant formulas, which contain different types of proteins, or breast milk to determine if different proteins have an effect on the type of bacteria that enters and lives in an infant's intestine early in life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amino acid based infant formula | Active Comparator |
| |
| Extensively hydrolyzed casein infant formula | Experimental |
| |
| Mother's own breast milk | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amino acid based infant formula | Other |
| ||
| Extensively hydrolyzed casein infant formula |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal microbiota measured at each visit | Sequencing and composition of samples | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight measured at each visit | Measurement collected with a calibrated infant scale | 8 weeks |
| Body length measured at each visit | Measurement collected with a standardized length board |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon Vanderhoof, M.D. | Mead Johnson and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Midwest Children's Health Research Institue | Lincoln | Nebraska | 68504 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33167908 | Derived | Kok CR, Brabec B, Chichlowski M, Harris CL, Moore N, Wampler JL, Vanderhoof J, Rose D, Hutkins R. Stool microbiome, pH and short/branched chain fatty acids in infants receiving extensively hydrolyzed formula, amino acid formula, or human milk through two months of age. BMC Microbiol. 2020 Nov 9;20(1):337. doi: 10.1186/s12866-020-01991-5. | |
| 33006765 |
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| Other |
|
| Mother's own breast milk | Other |
|
| 8 weeks |
| Head circumference measured at each visit | Measurement collected with a standardized measuring tape | 8 weeks |
| Parental recall of formula intake at each visit | 8 weeks |
| Stool collection at each visit | Composite measure of pH and short chain fatty acids | 8 weeks |
| Serious adverse events collected throughout the study period | 8 weeks |
| Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2. |