Impact of Early Feeding on Infant Immune Development
Mechanistic Effects of Early Life Feeding Exposure on Infant Inflammatory and Health Status
University of Idaho · NCT05986539
This study looks at how a mother's health affects her breastmilk and how that, in turn, influences her baby's immune system and overall health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Idaho (other) |
| Locations | 1 site (Moscow, Idaho) |
| Trial ID | NCT05986539 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how maternal health, specifically inflammation and body mass index, affects the composition of breastmilk and subsequently influences infant immune development. It aims to collect blood and fecal samples from healthy full-term infants at 2 and 4 months of age to analyze immune cell populations and inflammatory biomarkers. Additionally, breastmilk will be collected from lactating mothers to assess its inflammatory content. The study seeks to clarify the relationship between maternal health and infant health outcomes, particularly in the context of childhood obesity.
Who should consider this trial
Good fit: Ideal candidates include mothers in their third trimester of pregnancy or those with infants 5 weeks old or younger who plan to breastfeed or provide formula for at least 18 weeks.
Not a fit: Patients who are not healthy or do not plan to breastfeed/formula feed for the required duration may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how maternal health impacts infant immune development, potentially leading to improved breastfeeding practices and interventions to prevent childhood obesity.
How similar studies have performed: While there is limited research on this specific approach, studies examining the relationship between maternal health and infant outcomes have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Moscow, Idaho
- University of Idaho — Moscow, Idaho, United States (RECRUITING)
Study contacts
- Principal investigator: Bethaney Fehrenkamp, PhD — University of Idaho Clinical Assistant Professor
- Study coordinator: Bethaney Fehrenkamp, PhD
- Email: bethaney@uidaho.edu
- Phone: 208-885-1121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Maternal Behavior, Maternal Obesity, Breast Milk Collection, Infant Development