An interventional study of Infant fruit and Infant vegetable in Healthy Participants, Infants and Gastrointestinal Microbiota, sponsored by University of Delaware. Completed at 1 site in United States. Open to participants aged 5 Months to 7 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-17.
Sponsored by University of Delaware · Not applicable, Interventional, and Basic science
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.
University of Delaware is the lead sponsor of 128 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
Oatmeal cereal
Other: Infant grain
Pureed prunes
Other: Infant fruit
Pureed carrots
Other: Infant vegetable
Pureed beef
Other: Infant meat
Infants will be fed prune puree
Infants will be fed carrot puree
Infants will be fed beef puree
Infants will be fed oatmeal cereal
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
Time frame: Day 0, 3, 7, 10, 14
Plan to share: No
Ran from Jan 2023 to primary completion in Mar 2024, 13 months.
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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