Summary

for females ages 21-45 (full criteria)
healthy people welcome
at UC Davis
study started
estimated completion:
Jennifer Smilowitz (ucdavis) Lisa Oakes (ucdavis)

Description

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.

Official Title

The Infant MiND Study: An Examination of Infants' Microbiome, Nutrition, and Development Study.

Details

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.

Keywords

Microbial Colonization Infant Development Breastfeeding First foods Communicable Diseases Infection Sweet Potatos Pears

Eligibility

You can join if…

Open to females ages 21-45

  • 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 radius of UC Davis Medical Center (2221 Stockton Blvd, Sacramento, CA 95817).

You CAN'T join if...

  • 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), polycystic ovary syndrome, 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.

Location

  • University of California, Davis accepting new patients
    Davis California 95616 United States

Lead Scientists

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
Links
Details for this research project is available through the UC Davis InfantMiND website
ID
NCT03229863
Study Type
Interventional
Last Updated