Early Life Feeding Exposure and Infant Immune and Health Status.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of Idaho
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Mother at least 18 years of age
Mother is in third trimester (week 27 of gestation) or biological infant is 5 weeks of age or younger
Mother plans to continue to provide your infant breastmilk (by breastfeeding or by pumping) for at least 18 weeks (4.5 months) from your delivery date or mother plans to continue to provide formula exclusively to infant for at least 18 weeks of life.
Mother lives within a 45-mile radius of Study Site, or is willing to deliver samples for visits 2, 4, and 6.
Disqualifiers
Mother or Infant have participated or are currently participating in an interventional drug or device (non-observational) research study before.
Mother reports that they, or the infant, have had an adverse effect during a venous blood collection.
Infant was born less than 36 weeks of gestation.
Infant or mother have health conditions that increase the risk of study procedures.
Trial population
Study population is postnatal women and their infant dyads.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Observational
Other interventionThis study is only observational in nature and will not include an intervention.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Breastfeeding dyad1 intervention
Group B: Formula feeding dyads1 intervention
Trial outcomes
Primary outcomes
1
Characterize the change in systemic inflammatory profile of healthy full-term infants
We will investigate infant inflammation across the first 4.5 months of life in serum and feces using biomarkers C-reactive protein, tumor necrosis factor-alpha, and other inflammatory interleukins and cytokines.
Time frame
Through study completion, an average of 12 weeks.Secondary outcomes
1
Characterize the potential correlation between maternal systemic inflammation and inflammatory profile of the breastmilk.
We will explore how maternal systemic inflammation may correlate with inflammatory markers within the breastmilk. We hypothesize that maternal systemic inflammation and health status will be correlated with increased inflammatory markers in breast milk if breastfeeding.
Time frame
Through study completion, an average of 12 weeks.Other outcomes
1
Characterize the change in blood mononuclear cell distribution of healthy full term infants.
We will assess this relationship by flow cytometry analysis of peripheral blood mononuclear cells at 2 and 4 months of age. We expect to capture biological variation in circulating immune cell populations in the developing infant. We hypothesize that infants with elevated inflammation would also have greater inflammatory immune cell proportions than their formula-fed counterparts.
Time frame
Through study completion, an average of 12 weeks.Sponsors and contacts
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Source ClinicalTrials.gov