Abstract
Methods: For the PRIMA human milk cohort we aim to recruit 1000 mother–child pairs in the first month postpartum. At one week, one, three, and six months after birth, fresh human milk samples will be collected and processed. In order to identify protective components, the level of pathogen specific antibodies, T cell composition, Human milk oligosaccharides, as well as extracellular vesicles (EVs) will be analysed, in the milk samples in relation to clinical data which are collected using two-weekly parental questionnaires. The primary outcome of this study is the number of parent-reported medically attended respiratory infections. Secondary outcomes that will be measured are physician diagnosed (respiratory) infections and allergies during the first year of life.
Discussion: The PRIMA human milk cohort will be a large prospective healthy birth cohort in which we will use an integrated, multidisciplinary approach to identify the longitudinal effect human milk components that play a role in preventing (respiratory) infections and allergies during the first year of life. Ultimately, we believe that this study will provide novel insights into immunomodulatory components in human milk. This may allow for optimizing formula feeding for all non-breastfed infants.
| Original language | English |
|---|---|
| Article number | 152 |
| Pages (from-to) | 1-10 |
| Number of pages | 10 |
| Journal | BMC Infectious Diseases |
| Volume | 22 |
| Issue number | 1 |
| Early online date | 14 Feb 2022 |
| DOIs | |
| Publication status | Published - Dec 2022 |
Bibliographical note
© 2022, The Author(s).Funding
The study was funded by grants from the Dutch Ministry of Health, Welfare and Sport, the Wilhelmina Children’s Hospital and Nutricia B.V. None of the authors have a competing financial interest in relation to the presented work; JG, LK and BL are (partly) employed by Danone Nutricia Research. This research was supported by Regio Deal Foodvalley (grant nr 162135), the WKZ research fund-Nutricia call 2020 “Breast milk T cells: frontline protection for infants and mothers?” and from Danone Nutricia Research BV as part of a UMC Utrecht-Danone Nutricia Research BV collaboration grant “Early Life Nutrition and Immune Development” (Ministerie van Volksgezondheid, Welzijn en Sport, Universitair Medisch Centrum Utrecht, Danone Nutricia Research BV). The funders had no role in the study design, in the collection, analysis and interpretation of data. The funders had no role in the final decisions on the interpretation and dissemination of the results.
| Funders | Funder number |
|---|---|
| Early Life Nutrition and Immune Development | |
| Ministerie van Volksgezondheid, Welzijn en Sport, Universitair Medisch Centrum Utrecht | |
| Regio Deal Foodvalley | 162135 |
| UMC Utrecht-Danone Nutricia Research BV | |
| Wilhelmina Children’s Hospital and Nutricia B.V. None | |
| Danone Nutricia Research | |
| Nutricia Research Foundation | 20187710 |
| Ministerie van Volksgezondheid, Welzijn en Sport | |
| Universitair Medisch Centrum Utrecht |