Maternal BehaviorNCT05986539
Early Life Feeding Exposure and Infant Immune and Health Status.
An observational study of Maternal Behavior and Maternal Obesity, run by University of Idaho at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Behavior, Maternal Obesity, Breast Milk Collection
- What is being tested?
- Observational
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2024to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population is postnatal women and their infant dyads.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Idaho
Moscow, Idaho, 83844
Bethaney Fehrenkamp, PhD, 208-885-1121, bethaney@uidaho.edu
bethaney@uidaho.edu
About this study
Official title: Mechanistic Effects of Early Life Feeding Exposure on Infant Inflammatory and Health Status
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.
Read more
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.
Read the detailed description
The immune system of newborns is immature and undergoes rapid development during the first few months of life. Inflammation is a natural response to infection or tissue injury, but excessive or prolonged inflammation can be detrimental to immune development. Understanding the relationship between inflammation and immune development in healthy full-term infants is critical to developing effective interventions to promote healthy immune function in early life.
This project will collect blood samples from healthy full-term infants at 2 and 4 months of age. The samples will be analyzed using flow cytometry to quantify the proportions and activation status of different immune cell populations, such as T, B, natural killer, and monocytes. The analysis will also include quantifying intracellular cytokines to assess the functional capacity of the immune cells. The samples will be analyzed using established methods to measure biomarkers of inflammation, such as CRP, TNF-alpha, and other inflammatory interleukins and cytokines. This project will expand upon biomarkers previously examined to aid in the overall understanding of the role of inflammation in healthy immune development. Fecal samples will be collected from infants five times during the first 6 to 18 weeks of life. Fecal CRP and calprotectin levels will be quantified to detect low-level inflammation and enhance systemic results. Breastmilk will also be collected from lactating women at corresponding collection times to assess breastfeeding's impact on immune development. In addition to data collected on maternal BMI, maternal blood will be collected at 2 and 4 months postpartum to enhance investigations into maternal inflammatory status. Using existing clinical partnerships, 30 maternal-infant dyads will be recruited during the first 6 weeks of life and followed for 12 weeks. Dyads will include 15 breastfeeding infants, to be matched with 15 infants receiving formula or other non-human-based milk products (i.e., plant based formula). Dyads will be matched on infant sex and maternal BMI. A human milk sample will be collected at 6, 8, 12, 16 and 18 weeks postpartum in connection with infant fecal samples (Figure 1). Mothers can opt-in to collecting their own feces and saliva. Blood will be obtained from infants during recurring pediatric wellness visits. Mothers will also be asked to complete reoccurring surveys regarding their diet, perceived stress and anxiety, infant diet, food introduction, and general infant behavior or level of fussiness. Maternal demographics, including education level, household income, and food security, will be collected upon enrollment. Electronic medical records will be accessed related to prenatal care; maternal health and pre-existing conditions; birth records; and infant health status, including growth and incidence of infection and use of antibiotics. The investigators will measure the concentrations of inflammatory cytokines in fecal and blood samples from infants and in milk and blood samples from their mothers. Flow cytometry will analyze infant and maternal blood samples for circulating immune cell populations. When available, saliva samples will be analyzed for cortisol concentration. Remaining infant and maternal fecal samples will be retained for future microbiome investigations.
- Being tested
- Observational
- Medical subject headings
- Pregnancy in Obesity, Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Also called Observation only based on natural experiment of feeding groups
This study is only observational in nature and will not include an intervention.
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding dyad | Women, and their infants, that intend to exclusively breastfeed or begin using formula as supplemental to breastmilk throughout the study. Receives: Other: Observational | |
| Formula feeding dyads | Women, and their infants, that intend to exclusively use formula from 6-18 weeks of life, the duration of the study, Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, an average of 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start12 Jan 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Idaho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bethaney Fehrenkamp, University of Idaho
- Investigators
- Bethaney Fehrenkamp, PhD, Principal investigator, University of Idaho Clinical Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986539
- Sponsor's protocol ID
- 23-013
- Status last verified
- Jul 2024
- First submitted
- 21 Jun 2023
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only deidentified data or samples will be shared with other researchers. The PI will ensure data confidentiality and deidentification of all data.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic Effects of Early Life Feeding Exposure on Infant Inflammatory and Health Status
- ClinicalTrials.gov ID
- NCT05986539
- Acronym / sponsor ID
- 23-013
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of IdahoUniversity, hospital or other
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The immune system of newborns is immature and undergoes rapid development during the first few months of life. Inflammation is a natural response to infection or tissue injury, but excessive or prolonged inflammation can be detrimental to immune development. Understanding the relationship between inflammation and immune development in healthy full-term infants is critical to developing effective interventions to promote healthy immune function in early life.
This project will collect blood samples from healthy full-term infants at 2 and 4 months of age. The samples will be analyzed using flow cytometry to quantify the proportions and activation status of different immune cell populations, such as T, B, natural killer, and monocytes. The analysis will also include quantifying intracellular cytokines to assess the functional capacity of the immune cells. The samples will be analyzed using established methods to measure biomarkers of inflammation, such as CRP, TNF-alpha, and other inflammatory interleukins and cytokines. This project will expand upon biomarkers previously examined to aid in the overall understanding of the role of inflammation in healthy immune development. Fecal samples will be collected from infants five times during the first 6 to 18 weeks of life. Fecal CRP and calprotectin levels will be quantified to detect low-level inflammation and enhance systemic results. Breastmilk will also be collected from lactating women at corresponding collection times to assess breastfeeding's impact on immune development. In addition to data collected on maternal BMI, maternal blood will be collected at 2 and 4 months postpartum to enhance investigations into maternal inflammatory status. Using existing clinical partnerships, 30 maternal-infant dyads will be recruited during the first 6 weeks of life and followed for 12 weeks. Dyads will include 15 breastfeeding infants, to be matched with 15 infants receiving formula or other non-human-based milk products (i.e., plant based formula). Dyads will be matched on infant sex and maternal BMI. A human milk sample will be collected at 6, 8, 12, 16 and 18 weeks postpartum in connection with infant fecal samples (Figure 1). Mothers can opt-in to collecting their own feces and saliva. Blood will be obtained from infants during recurring pediatric wellness visits. Mothers will also be asked to complete reoccurring surveys regarding their diet, perceived stress and anxiety, infant diet, food introduction, and general infant behavior or level of fussiness. Maternal demographics, including education level, household income, and food security, will be collected upon enrollment. Electronic medical records will be accessed related to prenatal care; maternal health and pre-existing conditions; birth records; and infant health status, including growth and incidence of infection and use of antibiotics. The investigators will measure the concentrations of inflammatory cytokines in fecal and blood samples from infants and in milk and blood samples from their mothers. Flow cytometry will analyze infant and maternal blood samples for circulating immune cell populations. When available, saliva samples will be analyzed for cortisol concentration. Remaining infant and maternal fecal samples will be retained for future microbiome investigations.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding dyad | – | Other: ObservationalWomen, and their infants, that intend to exclusively breastfeed or begin using formula as supplemental to breastmilk throughout the study. |
| Formula feeding dyads | – | Other: ObservationalWomen, and their infants, that intend to exclusively use formula from 6-18 weeks of life, the duration of the study, |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population is postnatal women and their infant dyads.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalAlso: Observation only based on natural experiment of feeding groupsThis study is only observational in nature and will not include an intervention. | Other | Breastfeeding dyad, Formula feeding dyads |
Primary outcome
Characterize the change in systemic inflammatory profile of healthy full-term infants
Time frame: Through 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.
1 secondary outcome
Characterize the potential correlation between maternal systemic inflammation and inflammatory profile of the breastmilk.
Time frame: Through study completion, an average of 12 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Individual participant dataSharing planned: No. Only deidentified data or samples will be shared with other researchers. The PI will ensure data confidentiality and deidentification of all data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bethaney Fehrenkamp, PhD principal investigator
University of Idaho Clinical Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maternal Behavior and Maternal Obesity, run by University of Idaho at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bethaney Fehrenkamp, PhD (208-885-1121, bethaney@uidaho.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize the change in systemic inflammatory profile of healthy full-term infants (time frame: Through study completion, an average of 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.