RECRUITING

Early Life Feeding Exposure and Infant Immune and Health Status.

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Mechanistic Effects of Early Life Feeding Exposure on Infant Inflammatory and Health Status

Quick Facts

Study Start:2024-01-12
Study Completion:2025-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05986539

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Mother at least 18 years of age
  2. * Mother is in third trimester (week 27 of gestation) or biological infant is 5 weeks of age or younger
  3. * 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.
  4. * Mother lives within a 45-mile radius of Study Site, or is willing to deliver samples for visits 2, 4, and 6.
  5. * Mother willing to meet at (designated sample collection site) for visits 3 and 5 for sample collection and visit activities.
  6. * Mother willing to consent and comply with all aspects of the study protocol and methods, save the optional activities and optional sample collections.
  7. * Mother and infant are considered healthy by Principle Investigator.
  8. * For Formula Fed Group: Mother-Infant dyad is able to match to a Breastfed dyad using maternal BMI and infant sex.
  1. * Mother or Infant have participated or are currently participating in an interventional drug or device (non-observational) research study before.
  2. * Mother reports that they, or the infant, have had an adverse effect during a venous blood collection.
  3. * Infant was born less than 36 weeks of gestation.
  4. * Infant or mother have health conditions that increase the risk of study procedures.

Contacts and Locations

Study Contact

Bethaney Fehrenkamp, PhD
CONTACT
208-885-1121
bethaney@uidaho.edu

Principal Investigator

Bethaney Fehrenkamp, PhD
PRINCIPAL_INVESTIGATOR
University of Idaho Clinical Assistant Professor

Study Locations (Sites)

University of Idaho
Moscow, Idaho, 83844
United States

Collaborators and Investigators

Sponsor: University of Idaho

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-12
Study Completion Date2025-04-30

Study Record Updates

Study Start Date2024-01-12
Study Completion Date2025-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Maternal Behavior
  • Maternal Obesity
  • Breast Milk Collection
  • Infant Development