The European Breast Milk Collection

Short- and long-term benefits of breastfeeding to both mothers and infants have been well demonstrated. However, robust clinical lactation studies are rare and existing data cannot be confidently translated into evidence-based clinical practice. In order to provide evidence for how a medicine transfers to breastmilk, we need to test milk from mothers who need treatment during the post-partum period. To that end, ConcePTION WP4 is developing a research infrastructure to collect, store and analyse samples of breast milk and blood. We are building a European self-sustaining breast milk and blood collection, referring both to the activity of collecting at various European sites, and the physical storage of samples.   

The European Breast Milk Collection is structured as follows: Uppsala Biobank is the storage facility that receives, stores and manages the breast milk collection; the Analytical Centre in Uppsala; the ConcePTION database located in Utrecht that stores all clinical data and results from analyses.

The infrastructure is compliant with regulatory quality and ISO standards, and will be a platform for lactation studies for both universities and pharmaceutical companies: Helping to bridge the knowledge gap for women who want to breastfeed and need information on drug transfer into breast milk. The breastmilk and blood collection will be self-sustaining and live on after the project ends, supporting research on medicines safety in breastfeeding in the future!

Four demonstration projects are being conducted to study milk transfer of Amoxicillin, Metformin, Venlafaxine and Levocetirizine/cetirizine. The studies are carried out by different partners in the project and are intended to provide more information about the strength and feasibility of different methodological approaches. The results will inform our stakeholders (i.e. researchers in academic centers and industry, and regulators) about best practices. Samples will be collected on site, and shipped to the biobank in Uppsala, Sweden, where samples will also be analysed. Our ambition is to use these demonstration studies to provide researchers with adequate tools and analytical methods to carry out lactation studies and to set the standards at the European and international level.

Want more information about the studies?

We are currently recruiting breast milk donors in Norway who use Levocetirizine/Cetirizine. More information about the study (in Norwegian) at mn.uio.no/morsmelk.

Timeline(s):

  • Approval demonstrations studies (2021)
  • Plasma and breast milk sample collection (2021-2022)
  • Bioanalysis (2021-2022)
  • Modelling (2022-2023): to describe drugs’ disposition within mothers’ population; to identify covariates contributing to the population variability;
  • ConcePTION database (2023)
  • Share best practice (2024): SOP, publications, recommendations;
  • Develop and launch sustainability plan (2024)

Contact

Study leaders

Role of the breast milk collection in ConcePTION

European Breast Milk Collection at Uppsala Biobank

Analytical centre