The ConcePTION breast milk collection for clinical lactation studies
Whether or not to breastfeed your own child should be an informed decision, based on scientific evidence. The ConcePTION project carried out five human lactation demonstration studies to investigate how amoxicillin, levocetirizine, metformin, prednisolone and venlafaxine transfer from mother to infant during breastfeeding. In addition to informing decisions on how to prescribe these five medicines, the work provides a framework for future lactation studies.
The demonstration studies were investigator-driven and set up according to standardised protocols approved by appropriate ethical review boards and regulatory authorities and registered at EU-PAS and/or EudraCT, following ICH-GCP requirements. Samples are stored at Uppsala Biobank (Sweden) in accordance with Swedish legislative and regulatory frameworks for biobanking of tissue and blood samples.
The ConcePTION breast milk sample collections will be made available for future research related to lactation and medication, and become searchable through a specific BBMRI-ERIC breast-milk sample directory.
A multi-disciplinary Governing Board has been established IMI-ConcePTION sample collections. It consists of the principal investigators of the five demonstration studies and a representative of EFPIA. The role of the governing board is to give advice to sample controllers regarding requests for use.
Protocols for demonstration studies
- Levocetirizine/cetirizine levels in human milk – an observational, clinical study among breastfeeding women (EUPAS46213)
- Prediction of venlafaxine exposure trough breastfeeding (EUPAS103385)
- Evaluation of Amoxicillin diffusion in breast milk according to a population pharmacokinetic approach (N°EudraCT 2021-002247-30)
- Transfer of metformin into human breast milk and the plasma of breastfeeding children – A low intervention trial with biobanking of breast milk and plasma in Västra Götalandsregionen and Region Örebro (EUPAS105190 , CTIS 2022-501693-19-00)
- Transfer of prednisolone into human breast milk and plasma of breastfeeding children – A low intervention cohort study with biobanking of breast milk and plasma (EUPAS1000000059, CTIS 2023-508913-18-00)