An Examination of Infants' Microbiome, Nutrition, and Development Study.

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"Help us learn about the relationship between infant nutrition, gut health, and development!"
Age:
21-45 years old with infant child, 4 -7.5 months
Gender:
Female
Healthy Volunteers:
Yes
Keywords:
infant development, infant nutrition, infant gut health
Type:
Other study
Investigator:
Description
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.
This study requires
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.
Who can participate?
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 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).


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 >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.
Compensation
The Infant MiND Study is broken down into two parts: 1) the Main Study (described in this consent form), and 2) the Vocalization and Activity Monitoring Sub-study (described in a different consent form). If you complete both parts of the Infant MiND Study you may be compensated up to $410.
Full compensation to complete the Main Study is $335 and full compensation to complete the Sub-study is $75. To enroll in the Sub-study, you will be required to provide written consent on a different form that will be offered to you during your first CMB lab visit.
In appreciation of your time for completing the activities of the Main Study, at each lab and home visit you will receive financial compensation as 11 installments of Target gift cards to equal $335. This amount is intended to compensate your time and efforts as well as travel expenses incurred for laboratory visits. In addition, at each CMB lab visit we will give your baby a small toy or t-shirt (valuing no more than $10).
The $335 in gift cards to Target will be provide to you in Installments of $25 and $40. The $40 installments will be provided to you after completion of the CMB lab visits (Day 1-2), 14, 60 and 180. The $25 installments will be pro-rated based on your completion of study activities and provided by study personnel during the home visits on Days 7, 18, 30, 91, 121, 151, and 182-185.

Proration of the $25 installments will be based on a point system according to the number of study activities completed on or before each home visit. Biological samples collected and questionnaires/logs completed will be assigned a value of 1 point each, and the total number of activities completed on or before each home visit will be added together to produce a total number of possible points for that visit. The amount of compensation received will be determined by study personnel at each visit according to the number of activities completed compared to the total number of possible points. The proration point system for each visit is outlined below.
Day 7 (Home Visit)
From Day 0 to Day 6 you will be asked to collect (3) infant stool samples, (1) breast milk sample and (1) maternal stool sample and to complete (18) Daily Logs.
These study activities will be equal to 23 points (5+18) and proration will occur as follows: 0-11 points: $0; 12-17 points: $10; 18-23 points: $25.
However, to receive any compensation, you will be required to collect at least (1) infant stool sample, (1) breast milk sample if you are still breastfeeding, and (1) maternal stool sample.
Day 18 (Home Visit)
From Day 7 to Day 17, you will be asked to collect (4) infant stool samples and to complete (7) Food Logs and (33) Daily Logs.
These study activities are equal to 44 points (4+40) and proration will occur as follows: 0-22 points: $0; 23-33 points: $10; 34-44 points: $25.
However, to receive any compensation, you will be required to collect at least (1) infant stool sample.
Day 30 (Home Visit) From Day 18 to 29, you will be asked to collect (6) infant stool samples and (1) breast milk sample, and to complete (7) Food Logs and (36) Daily Logs.
These study activities are equal to 50 points (7+43) and proration will occur as follows: 0-25 points: $0; 26-38 points: $10; 39-50 points: $25.
However, to receive any compensation, you will be required to collect at least (1) infant stool and (1) breast milk sample if you are still breastfeeding.
Day 91 (Home Visit) From Day 30 to 90, you will be asked to collect (2) infant stool samples, (2) breast milk samples and (1) maternal stool sample.
To receive the full $25 installment of compensation, you are required to collect at least (1) infant stool sample, and (1) breast milk sample if you are still breastfeeding.
Day 121 (Home Visit)
From Day 91 to 120, you will be required to collect (1) infant stool sample, and (1) breast milk sample if you are still breastfeeding in order to receive the full $25 installment of compensation.

Day 151 (Home Visit)
From Day 121 to 150 you will be required to collect (1) infant stool sample and (1) breast milk sample if you are still breastfeeding in order to receive the full $25 installment of compensation.

Day 182-185 (Home Visit)
From Day 151 to 180 you will be required to collect (1) infant stool sample, (1) maternal stool sample and (1) breast milk sample if you are still breastfeeding in order to receive the full $25 installment of compensation.
Resources
Schedule
Study duration and period
Approximately six months
Location
Foods for Health Institute
1 Shields Avenue
RMI North Building
Davis, CA 95616
Contact
Michaela Debolt
Research Topic
Conditions:
  • Microbial Colonization
  • Infant Development

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