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

Primary Purpose

Microbial Colonization, Infant Development

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sweet Potatos
Pears
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Microbial Colonization focused on measuring Breastfeeding, First foods

Eligibility Criteria

21 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University of California, Davis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sweet Potatos

Pears

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Infant fecal microbiota composition
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).
Infant fecal microbial diversity
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)
Incidence of Adverse Events and Treatments
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.

Secondary Outcome Measures

Dietary composition
The relationship between the relative abundance of the infant fecal microbiome and function, and food glycan composition.
Infant cognition
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
Infant sleep
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.
Maternal secretor status and infant fecal microbiota
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.
Infant secretor status and fecal microbiota
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.
Maternal and infant fecal microbiota
The relationship between maternal and infant fecal microbiome.
Infant fecal human milk oligosaccharide concentrations
The change in infant fecal human milk oligosaccharide concentrations before, during and after introduction of complementary foods.
Infant weight
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
Human milk metabolomics
Determine the relationship between human milk metabolomics (metabolites, fatty acids, proteins) and the infant fecal microbiome.
Fecal metabolomics
Determine the relationship between fecal metabolites (metabolites, fatty acids, proteins) and fecal microbiome.
Infant gastrointestinal function
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).
Glycosidic linkages
Evaluate the glycosidic linkages in interventional foods and the infant fecal microbiome.

Full Information

First Posted
July 7, 2017
Last Updated
June 9, 2023
Sponsor
University of California, Davis
Collaborators
UC Davis Foods for Health Institute, Mengniu Dairy
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1. Study Identification

Unique Protocol Identification Number
NCT03229863
Brief Title
An Examination of Infants' Microbiome, Nutrition, and Development Study.
Acronym
IMiND
Official Title
The Infant MiND Study: An Examination of Infants' Microbiome, Nutrition, and Development Study.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 18, 2017 (Actual)
Primary Completion Date
March 10, 2020 (Actual)
Study Completion Date
March 10, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
UC Davis Foods for Health Institute, Mengniu Dairy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microbial Colonization, Infant Development
Keywords
Breastfeeding, First foods

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This study is designed as a combined randomized, crossover interventional and observational trial. At the start of the study, infants will enter a 7-day lead-in period to establish gut microbiome and GI tolerability baselines. After the 7-day lead-in period, infants will be randomized into one of two feeding arms comprised of two commercially available baby foods: sweet potato (SP) (Plum Organics, Just Sweet Potato) and pears (P) (Earth's Best, First Pears). The first food, either sweet potato or pears, will be consumed for 7 days followed by a 4-day washout period of exclusive breast milk before initiating the alternate 7-day feeding arm of pears or sweet potato, respectively. The second feeding arm will be followed by an additional 4-day washout period of exclusive breast milk before the introduction of any other solid foods. Once the first month of the study is complete, infants will enter an observational phase for the remainder of the study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sweet Potatos
Arm Type
Experimental
Arm Description
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.
Arm Title
Pears
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Sweet Potatos
Intervention Description
Plum Organics, Just Sweet Potato
Intervention Type
Other
Intervention Name(s)
Pears
Intervention Description
Earth's Best, First Pears
Primary Outcome Measure Information:
Title
Infant fecal microbiota composition
Description
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).
Time Frame
Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Title
Infant fecal microbial diversity
Description
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)
Time Frame
Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Title
Incidence of Adverse Events and Treatments
Description
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.
Time Frame
Baseline-days 180
Secondary Outcome Measure Information:
Title
Dietary composition
Description
The relationship between the relative abundance of the infant fecal microbiome and function, and food glycan composition.
Time Frame
Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Title
Infant cognition
Description
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
Time Frame
Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Title
Infant sleep
Description
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.
Time Frame
Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Title
Maternal secretor status and infant fecal microbiota
Description
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.
Time Frame
Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Title
Infant secretor status and fecal microbiota
Description
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.
Time Frame
Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Title
Maternal and infant fecal microbiota
Description
The relationship between maternal and infant fecal microbiome.
Time Frame
Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Title
Infant fecal human milk oligosaccharide concentrations
Description
The change in infant fecal human milk oligosaccharide concentrations before, during and after introduction of complementary foods.
Time Frame
Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Title
Infant weight
Description
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
Time Frame
Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Title
Human milk metabolomics
Description
Determine the relationship between human milk metabolomics (metabolites, fatty acids, proteins) and the infant fecal microbiome.
Time Frame
Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Title
Fecal metabolomics
Description
Determine the relationship between fecal metabolites (metabolites, fatty acids, proteins) and fecal microbiome.
Time Frame
Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Title
Infant gastrointestinal function
Description
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).
Time Frame
Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180
Title
Glycosidic linkages
Description
Evaluate the glycosidic linkages in interventional foods and the infant fecal microbiome.
Time Frame
Change from baseline to day 29

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Smilowitz, PhD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa Oakes, PhD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States

12. IPD Sharing Statement

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

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