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

June 9, 2023 updated by: University of California, Davis

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Davis, California, United States, 95616
        • University of California, Davis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sweet Potatos
Infants will consume commercially available baby food sweet potato (SP) (Plum Organics, Just Sweet Potato) for 7 days followed by a 4 day washout period of exclusive breast milk. Participants will be instructed to offer 1-2 tablespoons of sweet potato to their infant at least three times per day for seven days in a row.
Other: Sweet Potatos
Plum Organics, Just Sweet Potato
Experimental: Pears
Infants will consume commercially available baby food pear (P) (Earth's Best, First Pears) for 7 days followed by a 4 day washout period of exclusive breast milk. Participants will be instructed to offer 1-2 tablespoons of pears to their infant at least three times per day for seven days in a row.
Other: Pears
Earth's Best, First Pears

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
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)
Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
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.
Baseline-days 180

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary composition
Time Frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
The relationship between the relative abundance of the infant fecal microbiome and function, and food glycan composition.
Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Infant cognition
Time Frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
The relationship between the relative abundance of the infant fecal microbiome, microbial diversity and function, and infant cognition measured at 6, 8 and 12 months of age
Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Infant sleep
Time Frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
The relationship between the relative abundance of the infant fecal microbiome, microbial diversity and function, and infant sleep, activity and vocalizations measured throughout the study period.
Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Maternal secretor status and infant fecal microbiota
Time Frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
The relationship between maternal secretor status (via measurement of human milk oligosaccharides in breast milk) and the relative abundance of the infant fecal microbiome, microbial diversity and function before, during and after introduction of complementary foods.
Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Infant secretor status and fecal microbiota
Time Frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
The relationship between infant secretor status (via measurement of oligosaccharides in saliva) the relative abundance of the infant fecal microbiome, microbial diversity and function before, during and after introduction of complementary foods.
Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Maternal and infant fecal microbiota
Time Frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
The relationship between maternal and infant fecal microbiome.
Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Infant fecal human milk oligosaccharide concentrations
Time Frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
The change in infant fecal human milk oligosaccharide concentrations before, during and after introduction of complementary foods.
Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Infant weight
Time Frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Determine the relationship between infant weight and the relative abundance of the infant fecal microbiome, microbial diversity and function before, during and after introduction of complementary foods
Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Human milk metabolomics
Time Frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Determine the relationship between human milk metabolomics (metabolites, fatty acids, proteins) and the infant fecal microbiome.
Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Fecal metabolomics
Time Frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Determine the relationship between fecal metabolites (metabolites, fatty acids, proteins) and fecal microbiome.
Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Infant gastrointestinal function
Time Frame: Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Change in GI function as a means to monitor tolerability before, during and after introduction of complementary foods (through the measurement of fecal inflammatory mediators, GI barrier function markers and fecal LPS).
Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Glycosidic linkages
Time Frame: Change from baseline to day 29
Evaluate the glycosidic linkages in interventional foods and the infant fecal microbiome.
Change from baseline to day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

UC Davis Foods for Health Institute
Mengniu Dairy

Investigators

  • Principal Investigator: Lisa Oakes, PhD, University of California, Davis
  • Principal Investigator: Jennifer Smilowitz, PhD, University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2017

Primary Completion (Actual)

March 10, 2020

Study Completion (Estimated)

March 10, 2027

Study Registration Dates

First Submitted

July 7, 2017

First Submitted That Met QC Criteria

July 24, 2017

First Posted (Actual)

July 26, 2017

Study Record Updates

Last Update Posted (Estimated)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 9, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 919505

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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