Healthy Participants Clinical Trial
Official title:
Effect of First Complementary Foods on the Infant Gastrointestinal Microbiota: A Pilot Study
Verified date | May 2024 |
Source | University of Delaware |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates the effect of different complementary foods on the gastrointestinal microbiota of exclusively human milk fed infants.
Status | Completed |
Enrollment | 43 |
Est. completion date | March 12, 2024 |
Est. primary completion date | March 12, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 5 Months to 7 Months |
Eligibility | 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) - Infant is at least 5 months old, but not 8 or more months old - Infant consumes an exclusively human milk liquid diet only - Infant has not yet begun consuming solid foods - 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 - 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 food allergy |
Country | Name | City | State |
---|---|---|---|
United States | University of Delaware | Newark | Delaware |
Lead Sponsor | Collaborator |
---|---|
University of Delaware | American Society for Nutrition Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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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