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Completed

NCT Number: NCT03751137

GI Tract Biomarkers in Infants With Different Diets

Childhood obesity is increasing with more than one-third of adolescents currently overweight and one in five with obesity. The lifelong incidence of obesity-related morbidities is also increasing with childhood obesity. It is not yet known how obesity develops in an individual, specifically in early childhood. Further, it is unclear what mechanistic role a child's earliest nutrition or changing intestinal flora has in the etiology of obesity. Very young children are developing appetite and satiety patterns early in life. Nutrition and gut microbial flora have impact on how these processes unfold, but specific mechanisms are not yet well understood. The investigators hypothesize that formula-fed infants with changes in their microbial flora are more likely to have altered carbohydrate metabolism, evidenced by greater imbalances of fatty acid production, and are more likely to have accelerated growth trajectory due to satiety disruption. The investigators further hypothesize that altered carbohydrate metabolism, e.g. imbalances of short- and long-chain fatty acid levels in the gut, stimulate cellular stress and affect specific gut hormones. This study will compare the microbiome of the intestinal microbial flora in two groups of infants, one breast fed and the other formula fed, using longitudinally collected fecal samples from both groups. Samples will be subjected to shotgun metagenomic analysis and simultaneous metabolomic analysis. A bioinformatics approach will elucidate key differences among and between sample groups, and will further analyze bacterial gene expression levels related to carbohydrate metabolism. This study will compare the expression of human proteins involved in cellular stress response and gut peptide signaling by applying quantitative Reverse Transcriptase-Polymerase Chain Reaction to human messenger RNA isolated from the longitudinally collected samples from both groups. Finally, this study will monitor the trajectory of growth and feeding over the first 2 years of life. The project's focus on the influence of different early feeding types, microbial flora changes, and altered carbohydrate metabolism leading to disruption of gut-brain signaling will provide critical data for host:microbiome interactions and translational therapeutic targets.

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Key information

Age range

6 week–3 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Nemours Children's Hospital - Delaware

Wilmington, Delaware, 19803, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Otherwise healthy, male or female term infants
  • Exclusively breast or formula feeding
  • Never been exposed to oral or intravenous antibiotics or probiotics

Exclusion criteria

  • Maternal antibiotic use while breast-feeding
  • Infant or maternal use of probiotics
  • Current or recent (<14 days) gastrointestinal infection (viral, bacterial, or fungal)
  • Gastrointestinal mucosal disease, or significant constipation
  • Consuming formula that is not standard cow's milk formula
  • Infants on acid suppression medications or infants receiving high-density formula (>20 calories/ounce) may be enrolled and will be analyzed separately

Treatment and study plan

Primary outcomes

  1. Microbiome

    Time frame: Enrollment

    Metagenomic analysis of microbial organisms in infant's feces

  2. Microbiome

    Time frame: 6 months

    Metagenomic analysis of microbial organisms in infant's feces

  3. Microbiome

    Time frame: 12 months

    Metagenomic analysis of microbial organisms in infant's feces

  4. Microbiome

    Time frame: 18 months

    Metagenomic analysis of microbial organisms in infant's feces

Secondary outcomes

  1. Metabolome

    Time frame: Enrollment

    Metabolic products present in infant's feces

  2. Metabolome

    Time frame: 6 months

    Metabolic products present in infant's feces

  3. Metabolome

    Time frame: 12 months

    Metabolic products present in infant's feces

  4. Metabolome

    Time frame: 18 months

    Metabolic products present in infant's feces

  5. Gut hormone gene expression

    Time frame: Enrollment

    Transcriptional output of human epithelial cells in infant's feces

  6. Gut hormone gene expression

    Time frame: 6 months

    Transcriptional output of human epithelial cells in infant's feces

  7. Gut hormone gene expression

    Time frame: 12 months

    Transcriptional output of human epithelial cells in infant's feces

  8. Gut hormone gene expression

    Time frame: 18 months

    Transcriptional output of human epithelial cells in infant's feces

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Collaborators

  • University of Delaware

Registry information

Official study title

Longitudinal, Prospective Comparison of the Gastrointestinal Tract of Breastfed and Formula Fed Infants Via Fecal Analysis of the Microbiome, Intestinal Epithelial Cell Expression of Gut Hormones, and Fecal Analysis of the Metabolome

Important dates

Study start
2016
Primary completion
2021
Study completion
2025
First posted
Nov 23, 2018
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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