First Complementary Foods and the Infant Gastrointestinal Microbiota
Study Details
Study Description
Brief Summary
This study evaluates the effect of different complementary foods on the gastrointestinal microbiota of exclusively human milk fed infants.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
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 (rice 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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Infant cereal Rice cereal |
Other: Infant grain
Infants will be fed rice cereal
|
Experimental: Infant fruit Pureed prunes |
Other: Infant fruit
Infants will be fed prune puree
|
Experimental: Infant vegetable Pureed carrots |
Other: Infant vegetable
Infants will be fed carrot puree
|
Experimental: Infant meat Pureed beef |
Other: Infant meat
Infants will be fed beef puree
|
Outcome Measures
Primary Outcome Measures
- Change in gastrointestinal microbiota [Day 0, 4, 8, 12, 16, 20, 24, 28]
Composition of the gastrointestinal microbiota (family, genus, and species levels via shotgun metagenomic sequencing) before and after the introduction of solid food
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Infant was born vaginally
-
Infant was born full term
-
Infant has no significant gastrointestinal medical issues/diagnoses (e.g., gastroesophageal reflux, malabsorption syndromes, Celiac disease, Crohn's disease, or physician diagnosed or suspected food allergies)
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Infant is at least 5 months old, but not 8 or more months old
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Infant consumes an exclusively human milk liquid diet only
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Infant has not yet begun consuming solid foods
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Infant is developmentally ready to begin consuming solid foods (i.e., has good head and neck control, can sit upright when supported, and has at least doubled their birth weight)
-
Infant has not had antibiotics within the past month
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Infant's nursing mother has not had antibiotics within the past month
-
Parent/legal guardian is at least 18 years old
Exclusion Criteria:
-
Infant is not developmentally ready to begin solid foods
-
Infant has a family history of allergy to one or more of the four intervention foods (rice cereal, beef & gravy, prune, carrot)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Delaware | Newark | Delaware | United States | 19713 |
Sponsors and Collaborators
- University of Delaware
- American Society for Nutrition Foundation
Investigators
- Principal Investigator: Jillian Trabulsi, PhD, RD, University of Delaware
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1889964-1