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Formula feeding dyads for Breastmilk Expression

N/A
Recruiting
Led By Bethaney Fehrenkamp, PhD
Research Sponsored by University of Idaho
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 12 weeks.
Awards & highlights
No Placebo-Only Group

Summary

Background: Although breastfeeding has known protective effects, such as preventing childhood obesity, the specific mechanisms remain unclear. Idaho has a high breastfeeding initiation rate (92%) but a significant prevalence of childhood obesity (30.5% overweight/obese). Limited research exists on the impact of maternal inflammation, maternal body mass index (BMI), C-reactive protein (CRP), and interleukin-6 (IL-6) concentrations in breastmilk on infant health outcomes, especially in healthy full-term infants. Objective: This study aims to expand understanding of the role of maternal inflammation on breastmilk composition and its effect on infant immune development. The investigators seek to investigate the relationship between maternal health status, breastmilk inflammatory concentrations, and balanced immune development in infants. Additionally, the investigators aim to explore the potential influence of early diet exposure, including maternal inflammatory status, on the risk of obesity and other inflammatory conditions. Methods: Healthy full-term infants (breastfed/formula-fed) and their mothers will be recruited. Maternal inflammation markers (BMI, CRP, IL-6) and immune markers in infants will be analyzed. Flow cytometry will assess immune populations. Correlations between maternal systemic inflammation, infant inflammation, and breastmilk inflammatory markers will be examined for breastfeeding mothers. Outcomes: The investigators hypothesize breastfed infants will display a more favorable anti-inflammatory profile. This study will identify factors influencing immune development and potential pathways linking early-life exposures to long-term health outcomes. Findings will inform strategies for promoting balanced immune development and elucidate the role of early diet exposure, including maternal inflammation, as a protective or risk factor for obesity and inflammatory conditions.

Eligible Conditions
  • Breastmilk Expression
  • Maternal Behavior
  • Maternal Obesity
  • Infant Development

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 12 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 12 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Characterize the change in systemic inflammatory profile of healthy full-term infants
Secondary study objectives
Characterize the potential correlation between maternal systemic inflammation and inflammatory profile of the breastmilk.
Other study objectives
Characterize the change in blood mononuclear cell distribution of healthy full term infants.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Formula feeding dyadsExperimental Treatment1 Intervention
Women, and their infants, that intend to exclusively use formula from 6-18 weeks of life, the duration of the study,
Group II: Breastfeeding dyadExperimental Treatment1 Intervention
Women, and their infants, that intend to exclusively breastfeed or begin using formula as supplemental to breastmilk throughout the study.

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Who is running the clinical trial?

University of IdahoLead Sponsor
19 Previous Clinical Trials
2,645 Total Patients Enrolled
Bethaney Fehrenkamp, PhDPrincipal InvestigatorUniversity of Idaho Clinical Assistant Professor
~20 spots leftby Apr 2025