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

NCT03229863 | Active Not Recruiting

• 1 other identifier: 919505
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant Development; Microbial Colonization

Keywords

Breastfeeding; First foods

Outcome Measures

Primary Outcomes (3)

• 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).

  Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180

• 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)

  Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180

• 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.

  Baseline-days 180

Secondary Outcomes (12)

• Dietary composition

  Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180

• Infant cognition

  Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180

• Infant sleep

  Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180

• Maternal secretor status and infant fecal microbiota

  Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180

• Infant secretor status and fecal microbiota

  Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180

Study Arms (2)

Sweet Potatos

EXPERIMENTAL

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

Pears

EXPERIMENTAL

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

Interventions

Sweet Potatos OTHER

Plum Organics, Just Sweet Potato

Sweet Potatos

Pears OTHER

Earth's Best, First Pears

Pears

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify 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 \>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;

Sponsors & Collaborators

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

Study Sites (1)

University of California, Davis

Davis, California, 95616, United States

Location

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Related Links

• Learn more or sign up for the study here!

MeSH Terms

Conditions

Communicable Diseases; Breast Feeding

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Study Officials

• Jennifer Smilowitz, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

• Lisa Oakes, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 26, 2017
• Study Start: April 18, 2017
• Primary Completion: March 10, 2020
• Study Completion (Estimated): March 10, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-12

Locations

US (1)