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Early Life Feeding and Infant Immune Health

This observational study is looking at how early life feeding, like breastfeeding or formula feeding, affects a baby's immune system and overall health. Researchers want to understand if a mother's inflammation or body mass index (BMI) impacts the breast milk and, in turn, the baby's immune development. They will be studying healthy, full-term infants and their mothers. The main goal is to see how the baby's immune system changes over the first few months of life. You may be able to join if you are at least 18 years old, in your third trimester or your baby is 5 weeks old or younger, and you plan to breastfeed or formula feed for at least 18 weeks. This study is not testing a new medication; it's simply observing and collecting information.

Study design
This is an observational study with a planned enrollment of 60 participants. It is not testing an intervention but rather observing natural processes.
What's involved
You would provide blood samples from your infant at 2 and 4 months of age, and fecal samples from your infant five times during the first 6 to 18 weeks of life.
Compensation
Not stated in the trial record.
Follow-up
Infants will be followed through study completion, an average of 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05986539

Early Life Feeding Exposure and Infant Immune and Health Status.

UNKNOWN
Not specifiedAges 18+Observational
University of Idaho
~60 participants
Updated 2024-07-26 on ClinicalTrials.gov
What's tested:Observational

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Characterize the change in systemic inflammatory profile of healthy full-term infants
Measured over Through study completion, an average of 12 weeks.

Conditions

Maternal Behavior
Maternal Obesity
Breast Milk Collection
Infant Development

Explore related trials

Healthy

Where it's being run

1 sites across 1 states
Idaho1

Study leadership

  • Bethaney Fehrenkamp, PhD · PRINCIPAL_INVESTIGATOR · University of Idaho Clinical Assistant Professor

Who to contact

Bethaney Fehrenkamp, PhD
[email protected]
208-885-1121
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
Mother willing to meet at (designated sample collection site) for visits 3 and 5 for sample collection and visit activities.
Mother willing to consent and comply with all aspects of the study protocol and methods, save the optional activities and optional sample collections.
Mother and infant are considered healthy by Principle Investigator.
For Formula Fed Group: Mother-Infant dyad is able to match to a Breastfed dyad using maternal BMI and infant sex.

Exclusion

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.

What this trial measures

  • Characterize the change in systemic inflammatory profile of healthy full-term infantsThrough study completion, an average of 12 weeks.

    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.