21-45 years old with infant child, 4 -7.5 months
infant development, infant nutrition, infant gut health
This study will last about 6 months until your baby turns 1 year old, covering the time when your baby is transitioning from exclusively breastfeeding (or breast milk consumption from a bottle or cup) to eating solid foods. During this time, you will be asked to come to the Center for Mind and Brain (CMB) lab in Davis four times with your baby. Additionally, our study personnel will visit you at your home approximately seven times to pick up your biological samples (stool, milk and saliva) and daily logs and administer online questionnaries.
Your enrollment visit (Day 0) is scheduled before your baby has started eating any solid foods and is exclusively breastfed (or exclusively breast milk fed). On this day you will learn about the study activities, receive instructions on how to fill out daily logs and collect biological samples; and you will complete online health questionnaires. Additionally, your baby will be assessed for developmental readiness to consume solid foods. The enrollment visit will last about 2 hours long.
The first visit to the CMB lab should occur on study Day 1 or Day 2 (but must be before or on Day 6) and will last about 2 hours long. The second visit to the CMB lab will be scheduled to occur on study Day 14; the third visit will occur when your baby is about 8 months old, and the last visit will be scheduled around your baby’s first birthday. During these CMB lab visits, we will assess your baby’s cognitive and motor development and ask you to fill out an online questionnaire about your baby’s motor development. We will schedule the CMB lab visits to be long enough to allow us to complete these tasks, answer any questions you may have, take breaks as needed, and make sure both you and your baby are comfortable. We have a welcoming space in our lab with comfortable furniture and infant-friendly toys. The second, third and last appointments that occur at the CMB lab will be approximately 60 to 90 minutes in duration.
In between these lab visits, one of our study personnel will visit you at your home to transport the stool, milk and saliva samples you collected, administer online questionnaires, and provide you with additional study materials (for example, extra sample collection tubes). During these visits (and by phone call or text message as needed), our study personnel will give you additional instructions and answer any additional questions you may have. These at-home visits will take approximately 30 to 60 minutes in duration depending on the tasks that will be completed on each study day.
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 first month of the study;
Term infants born >37 weeks gestation;
Mother-infant pairs who live within a 20-mile radius from UC Davis campus in Davis, CA (includes Woodland, Vacaville, Dixon and surrounding areas) or within a 20-mile UCDMC (2221 Stockton Blvd, Sacramento, CA 95817).
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 >29.9), 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;
Infants who have consumed infant formula more than 10 days between birth and 4 weeks prior to screening;
Infants who have consumed any solids;
Mothers who plan to feed infants solids before 5 months of age;
Mothers who plan to administer probiotics on a regular basis to infants anytime throughout the study duration;
Infants who have consumed probiotics within the past 4 weeks;
Mothers who live in more than one location (should only live in one house to ensure samples are correctly collected and stored);
Infants who have hypotonia,
Infants who have been diagnosed with any medical or nutritional condition that would require iron supplementation.
Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.