This study is examining the relationship between infant nutrition, gut health, and development. The fecal microbiota changes and develops, in large part due to the food that infants eat. These changes are important for many aspects of development. This study is designed to examine how the fecal microbiota changes when exclusively breastfed infants are first introduced to solid food, and how changes of the fecal microbiota are related to other aspects of development.
The purpose of this study is to determine: 1) how the gut bacteria of exclusively breastfed infants changes in response to ingesting solid foods; 2) how infant cognition develops in response to ingesting solid foods; and 3) the relationship between infant gut bacteria and infant cognition during the first year of life. This study is designed to determine how specific complex carbohydrates in commonly used first foods encourage the growth of different bacteria in the infant gut. The two foods used in this study are commercially-available sweet potato (Plum Organics) and pear (Earth's Best). These two foods have been chosen because they differ substantially from each other in their carbohydrate composition. For example, sweet potato is mostly made up of starch which is digestible and pear is made up of other types of sugars found in fruits and vegetables that are not digestible and may have "prebiotic" effects (food for good bacteria in the gut). Thus, the use of these two foods could provide a good contrast for comparing how gut bacteria respond to different carbohydrate compositions during complementary feeding.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
Plum Organics, Just Sweet Potato
Earth's Best, First Pears
University of California, Davis
Davis, California, United States
Infant fecal microbiota composition
The difference in the relative abundance of the infant fecal microbiome at the order level (top 22 taxonomic orders with abundance expressed as both on log10 scale and a percent of total bacteria) between baseline and post-complementary food intake for each intervention arm (sweet potato vs. pear).
Time frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Infant fecal microbial diversity
The difference in the infant fecal microbial diversity and microbial function between baseline and post-complementary food intake for each arm (sweet potato vs. pear)
Time frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Incidence of Adverse Events and Treatments
Incidence of gastrointestinal symptoms (discomfort passing bowel movements, vomiting, constipation, colic or irritability), illnesses, health care visits for sickness, high fevers, antibiotic and medication use.
Time frame: Baseline-days 180
Dietary composition
The relationship between the relative abundance of the infant fecal microbiome and function, and food glycan composition.
Time frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Infant cognition
The relationship between the relative abundance of the infant fecal microbiome, microbial diversity and function, and infant cognition measured at 6, 8 and 12 months of age
Time frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Infant sleep
The relationship between the relative abundance of the infant fecal microbiome, microbial diversity and function, and infant sleep, activity and vocalizations measured throughout the study period.
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Time frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Maternal secretor status and infant fecal microbiota
The relationship between maternal secretor status (via measurement of human milk oligosaccharides in breast milk) and the relative abundance of the infant fecal microbiome, microbial diversity and function before, during and after introduction of complementary foods.
Time frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Infant secretor status and fecal microbiota
The relationship between infant secretor status (via measurement of oligosaccharides in saliva) the relative abundance of the infant fecal microbiome, microbial diversity and function before, during and after introduction of complementary foods.
Time frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Maternal and infant fecal microbiota
The relationship between maternal and infant fecal microbiome.
Time frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Infant fecal human milk oligosaccharide concentrations
The change in infant fecal human milk oligosaccharide concentrations before, during and after introduction of complementary foods.
Time frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Infant weight
Determine the relationship between infant weight and the relative abundance of the infant fecal microbiome, microbial diversity and function before, during and after introduction of complementary foods
Time frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Human milk metabolomics
Determine the relationship between human milk metabolomics (metabolites, fatty acids, proteins) and the infant fecal microbiome.
Time frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Fecal metabolomics
Determine the relationship between fecal metabolites (metabolites, fatty acids, proteins) and fecal microbiome.
Time frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Infant gastrointestinal function
Change in GI function as a means to monitor tolerability before, during and after introduction of complementary foods (through the measurement of fecal inflammatory mediators, GI barrier function markers and fecal LPS).
Time frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Glycosidic linkages
Evaluate the glycosidic linkages in interventional foods and the infant fecal microbiome.
Time frame: Change from baseline to day 29