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

Sponsor
University of California, Davis (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03229863
Collaborator
UC Davis Foods for Health Institute (Other), Mengniu Dairy (Other)
102
Enrollment
1
Location
2
Arms
118.7
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Sweet Potatos
  • Other: Pears
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
102 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention 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.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)
Primary Purpose:
Treatment
Official Title:
The Infant MiND Study: An Examination of Infants' Microbiome, Nutrition, and Development Study.
Actual Study Start Date :
Apr 18, 2017
Actual Primary Completion Date :
Mar 10, 2020
Anticipated Study Completion Date :
Mar 10, 2027

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Infant fecal microbiota composition [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).

  2. Infant fecal microbial diversity [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)

  3. Incidence of Adverse Events and Treatments [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.

Secondary Outcome Measures

  1. Dietary composition [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.

  2. Infant cognition [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

  3. Infant sleep [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.

  4. Maternal secretor status and infant fecal microbiota [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.

  5. Infant secretor status and fecal microbiota [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.

  6. Maternal and infant fecal microbiota [Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180]

    The relationship between maternal and infant fecal microbiome.

  7. Infant fecal human milk oligosaccharide concentrations [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.

  8. Infant weight [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

  9. Human milk metabolomics [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.

  10. Fecal metabolomics [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.

  11. Infant gastrointestinal function [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).

  12. Glycosidic linkages [Change from baseline to day 29]

    Evaluate the glycosidic linkages in interventional foods and the infant fecal microbiome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California, Davis Davis California United States 95616

Sponsors and Collaborators

  • University of California, Davis
  • UC Davis Foods for Health Institute
  • Mengniu Dairy

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT03229863
Other Study ID Numbers:
  • 919505
First Posted:
Jul 26, 2017
Last Update Posted:
Jan 28, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of California, Davis
Breastfeeding
First foods
Additional relevant MeSH terms:
Communicable Diseases
Infections

Study Results

No Results Posted as of Jan 28, 2022