Status:
ACTIVE_NOT_RECRUITING
An Examination of Infants' Microbiome, Nutrition, and Development Study.
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
UC Davis Foods for Health Institute
Mengniu Dairy
Conditions:
Microbial Colonization
Infant Development
Eligibility:
FEMALE
21-45 years
Phase:
NA
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...
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 ingest...
Eligibility Criteria
Inclusion
- 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
- 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;
- 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 any probiotics to infants throughout the feeding intervention period (first 18 days of the study);
- Infants who have consumed probiotics containing Bifidobacterium within the past 4 weeks or other probiotics within the past 7 days;
- 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.
- Infants who on average pass less than one stool per week.
Key Trial Info
Start Date :
April 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2027
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT03229863
Start Date
April 18 2017
End Date
March 10 2027
Last Update
December 5 2025
Active Locations (1)
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1
University of California, Davis
Davis, California, United States, 95616