First Complementary Foods and the Infant Gastrointestinal Microbiota

University of Delaware43 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Healthy Participants Infants Gastrointestinal Microbiota

Interventions

Infant fruitOTHER

Infants will be fed prune puree

Infant vegetableOTHER

Infants will be fed carrot puree

Infant meatOTHER

Infants will be fed beef puree

Infant grain

Eligibility

Sex: ALLMin age: 5 MonthsMax age: 7 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Delaware

Newark, Delaware, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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