The Infant MiND Study: An Examination of Infants' Microbiome, Nutrition, and Development Study.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Microbial Colonization
- Sponsor
- University of California, Davis
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Infant fecal microbiota composition
- Status
- Active, Not Recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women, age 21 to 45 years who have delivered a healthy single infant by vaginal delivery and their infants, age 4 to 7.5 months;
- •Infants who are developmentally ready for solids;
- •Generally healthy women and infants;
- •Mothers who plan to exclusively (without solids or infant formula) breastfeed (at the breast or feed breast milk by bottle) their infants for at least 5 months of age and plan to continue to breastfeed with solids and/or infant formula until 12 months of age;
- •Mothers who are willing to either use their own breast pump, or hand-express, or use a manual pump provided by the study to collect milk samples;
- •Mothers who are willing to refrain from feeding their infants infant formula, non-study solid foods; probiotic or iron supplements (confounding variables of the intestinal microbiome) before the end of the feeding intervention period;
- •Term infants born \>37 weeks gestation;
- •Mother-infant pairs who live within a 20-mile radius from University of California, Davis campus in Davis, California (includes Woodland, Vacaville, Dixon and surrounding areas) or within a 20-mile radius of the University of California, Davis Medical Center (UCDMC) (2221 Stockton Blvd, Sacramento, CA 95817).
Exclusion Criteria
- •Infants with any GI tract abnormalities;
- •Infants born by cesarean section;
- •Family history of immunodeficiency syndrome(s);
- •Multiple infants born to one mother at the same time (no twins, triplets, etc.);
- •Infants born with medical complications such as: respiratory distress syndrome, birth defects, and infection;
- •Mothers diagnosed with any metabolic or endocrine, liver, kidney disease, any autoimmune disease, cirrhosis, hepatitis C, HIV, AIDS, cancer, obesity (pre-pregnancy BMI \>34.9), polycystic ovary syndrome (PCOS), celiac disease, Crohn's disease, heart disease, hyper- or hypothyroidism, hyper- or hypotension (including pre-eclampsia), type 1 or type 2 diabetes.
- •Mothers who smoked cigarettes less than one month before becoming pregnant, during pregnancy, and currently or mothers who plan to initiate smoking during the study duration;
- •Infants who have taken antibiotics within the past 4 weeks;
- •Infants who have taken iron supplements within the past 4 weeks;
- •Infants who have consumed infant formula in the past 4 weeks;
Outcomes
Primary Outcomes
Infant fecal microbiota composition
Time Frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
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).
Infant fecal microbial diversity
Time Frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
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)
Incidence of Adverse Events and Treatments
Time Frame: Baseline-days 180
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.
Secondary Outcomes
- Infant secretor status and fecal microbiota(Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180)
- Infant gastrointestinal function(Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180)
- Maternal secretor status and infant fecal microbiota(Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180)
- Glycosidic linkages(Change from baseline to day 29)
- Dietary composition(Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180)
- Maternal and infant fecal microbiota(Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180)
- Infant fecal human milk oligosaccharide concentrations(Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180)
- Human milk metabolomics(Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180)
- Fecal metabolomics(Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180)
- Infant cognition(Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180)
- Infant sleep(Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180)
- Infant weight(Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180)