Effect of First Complementary Foods on the Infant Gastrointestinal Microbiota: A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Delaware
- Enrollment
- 43
- Locations
- 2
- Primary Endpoint
- Change in gastrointestinal microbiota
Study Overview
Brief Summary
This study evaluates the effect of different complementary foods on the gastrointestinal microbiota of exclusively human milk fed infants.
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 (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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 5 Months to 7 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Change in gastrointestinal microbiota
Time Frame: Day 0, 3, 7, 10, 14
Composition of the gastrointestinal microbiota (family, genus, and species levels via shotgun metagenomic sequencing) before and after the introduction of solid food
Secondary Outcomes
No secondary outcomes reported
Investigators
Jill Trabulsi
Associate Professor
University of Delaware