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| Name | Class |
|---|---|
| American Society for Nutrition | OTHER |
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This study evaluates the effect of different complementary foods on the gastrointestinal microbiota of exclusively human milk fed infants.
The introduction of solid foods plays a role in shaping the microbial communities of the gastrointestinal microbiota. This randomized, controlled, single-blinded trial will evaluate the effect of four infant foods (oatmeal cereal, carrot puree, prune puree, beef and gravy puree) on the gastrointestinal microbiota of exclusively human milk fed infants that have not previously consumed solid foods and who are developmentally ready for the introduction of solid foods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infant cereal | Active Comparator | Oatmeal cereal |
|
| Infant fruit | Experimental | Pureed prunes |
|
| Infant vegetable | Experimental | Pureed carrots |
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| Infant meat | Experimental | Pureed beef |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infant fruit | Other | Infants will be fed prune puree |
| |
| Infant vegetable |
| Measure | Description | Time Frame |
|---|---|---|
| Change in gastrointestinal microbiota | Composition of the gastrointestinal microbiota (family, genus, and species levels via shotgun metagenomic sequencing) before and after the introduction of solid food | Day 0, 3, 7, 10, 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jillian Trabulsi, PhD, RD | University of Delaware | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Delaware | Newark | Delaware | 19713 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41825736 | Derived | Ferro LE, Bittinger K, Trudo SP, Kim JK, Hunt CM, Brewer B, Polson SW, Trabulsi JC. Influence of Singular First Foods on the Infant Gut Microbiome: A Randomized Controlled Trial. J Nutr. 2026 May;156(5):101470. doi: 10.1016/j.tjnut.2026.101470. Epub 2026 Mar 11. |
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| Other |
Infants will be fed carrot puree |
|
| Infant meat | Other | Infants will be fed beef puree |
|
| Infant grain | Other | Infants will be fed oatmeal cereal |
|