Project Title: Perspectives on the Participation of Pregnant and Breastfeeding Women in Clinical Trials: Views of Sponsors, Researchers, and Patients
Project Objective: The participation of pregnant and breastfeeding women in clinical trials remains one of the most neglected and underrepresented areas of contemporary clinical research methodology and bioethics. For decades, researchers have approached these populations with considerable caution, routinely excluding pregnant and lactating women from clinical studies due to concerns about the safety of the fetus and the breastfed infant. In practice, however, this approach has created a paradox: pregnant and breastfeeding women continue to require pharmacological treatment, yet clinical decisions are often made on the basis of limited evidence regarding the efficacy and safety of medicines in these populations.
Contemporary discussions have therefore shifted away from the question of whether pregnant and breastfeeding women should be included in clinical research and toward how such inclusion can be achieved safely and ethically. This shift reflects a growing recognition that systematic exclusion does not eliminate risk but rather transfers it to routine clinical practice, where medications are frequently prescribed without sufficient evidence to support their safe use in these groups.
The aim of this project is to investigate the knowledge, attitudes, and perceptions regarding the participation of pregnant and breastfeeding women in clinical trials from the perspectives of sponsors, researchers, and patients. The study also seeks to identify factors influencing their inclusion in clinical research and to explore potential directions for future policy and practice improvements.
Principal Investigator: Julia Krzemińska, MSc
Doctoral Supervisor: Prof. Aleksandra Wesołowska, PhD, DSc in Medical and Health Sciences
Funding Source: The project is funded by the Medical University of Warsaw through its internal funding scheme under the Student Mini-Grant 2026 competition.
Project Title:Attitudes Towards the Inclusion of Pregnant and Breastfeeding Women in Clinical Research: Perspectives of Sponsors, Investigators, and Patients
Project Objective:The aim of the project is to assess the safety of psychiatric medications used during lactation and their impact on both breastfeeding mothers and infants. The study will evaluate drug transfer into human milk, infant exposure, and maternal and child health outcomes, while also examining patient perspectives on participation in lactation safety studies. In addition, the project will assess the applicability of newly introduced adverse event definitions in the MedDRA system and contribute to the development of standardized methodologies in pharmacovigilance for lactating populations.
Principal Investigator: Paulo Vitor Gonçalves, MSc
Doctoral Supervisor: Prof. Aleksandra Wesołowska, PhD, DSc in Medical and Health Sciences
Assistant Doctoral Supervisor: Oliwia Gawlik-Kotelnica, PhD
Funding Source: The project is funded through internal funding provided by the Medical University of Warsaw under the Young Researcher (Młody Badacz) programme.
Project Partners: The project is carried out through a collaboration between the Laboratory of Human Milk and Lactation Research , Medical University of Warsaw; the Department of Affective and Psychotic Disorders, Medical University of Łódź; and the Laboratory of Quantitative Analysis of Drugs and Metabolites (MS Lab), Institute of Biochemistry and Biophysics, Polish Academy of Sciences.
Project Title: Human Milk Composition in Mothers Diagnosed with Gestational Diabetes Mellitus (GDM)Cel projektu:
Project Objective: The aim of this project is to investigate the impact of gestational diabetes mellitus (GDM) on the composition of mature human milk during the second month of lactation. Particular attention will be paid to the concentrations of macronutrients (proteins, lactose, and fats), selected fatty acids (including omega-3 and omega-6 fatty acids), and hormones such as leptin, ghrelin, adiponectin, insulin, and insulin-like growth factor (IGF).
Current scientific evidence regarding the effects of gestational diabetes on mature human milk composition remains inconclusive, and it is still unclear whether a history of GDM significantly influences milk composition. The results of this study will help address this knowledge gap and contribute to improving the evidence base supporting the safety and benefits of breastfeeding for both infants and their mothers.
Principal Investigator: Magdalena Babiszewska-Aksamit, PhD
Research Team Member from the Laboratory: Aleksandra Mołas, MSc
Funding Source: This project is funded by the National Science Centre (NCN), Poland, under the MINIATURA 8 programme (Grant No. 2024/08/X/NZ9/01151).
Project Partners: The study is conducted by the Laboratory of Human Milk and Lactation Research, Department of Medical Biology, Medical University of Warsaw, in collaboration with the University Centre for Women's and Newborn Health of the Medical University of Warsaw.
Project Title:Early Supplementation in the Prevention of Cow’s Milk Allergy in Breastfed Infants: A Randomized Controlled Medical Trial
Project Objective: The aim of this study is to determine whether early, short-term exposure to selected nutritional interventions in breastfed infants can prevent the development of cow’s milk protein allergy. In particular, the study will evaluate whether the administration of small amounts of infant formula based on cow’s milk proteins, amino acid-based formulas, or pasteurized donor human milk during the first months of life promotes the development of immune tolerance.
The findings of this study may contribute to the development of evidence-based strategies for the prevention of food allergies in infants and provide new insights into the role of early nutritional exposures in shaping immune responses.
Principal Investigator: Andrea Horvath, MD, PhD, DSc
Research Team Members from the Laboratory:
- Prof. Aleksandra Wesołowska, PhD, DSc in Medical and Health Sciences
- Aleksandra Mołas, MSc
Funding Source: This project is funded by the Polish Medical Research Agency (ABM) under the 2nd Edition of the Head-to-Head Research Competition for Non-Commercial Clinical Trials and Research Experiments (2023) (Grant No. 2023/ABM/01/000037).
Project Title:Breastfeeding and Human Milk Components in the Prevention of Early Childhood Caries (ECC): A Prospective Observational Study
Project Objective: The aim of this project is to identify the components of human milk involved in the prevention of early childhood caries (ECC) and to evaluate the impact of infant feeding practices on the development of the oral microbiome and the subsequent risk of dental caries.
The project also includes an analysis of the effects of selected human milk components on bacterial biofilm formation using in vitro models designed to reflect conditions within the oral cavity. The findings are expected to contribute to a better understanding of the mechanisms through which human milk may support oral health and help prevent early childhood caries.
Principal Investigator: Julia Śladowska, MSc
Doctoral Supervisor: Prof. Aleksandra Wesołowska, PhD, DSc in Medical and Health Sciences
Assistant Doctoral Supervisor: Anna Minkiewicz-Zochniak, PhD in Medical and Health Sciences
Project Partners: The study is conducted by the Laboratory of Human Milk and Lactation Research, Department of Medical Biology, Medical University of Warsaw, in collaboration with the Department of Paediatric Dentistry, University Dental Centre of the Medical University of Warsaw.
Project Title: Breastfeeding Barriers and Postnatal Care: Implications for Clinical Practice and Human Milk Banking
Project Objectives: Breastfeeding is widely recognised as one of the most effective interventions for improving maternal and infant health. Despite its well-established benefits, many women encounter medical, social, and healthcare-related barriers that influence breastfeeding initiation, duration, and exclusivity. Understanding these barriers is essential for developing evidence-based strategies that support mothers and optimise infant nutrition. The aim of my doctoral research is to investigate factors that influence breastfeeding practices and postnatal care, with particular attention to clinical conditions that may create uncertainty regarding breastfeeding recommendations. These include infectious diseases such as cytomegalovirus (CMV), as well as other maternal and infant health conditions that can affect feeding decisions and access to appropriate support.
Principal Investigator: Laksheetha Santhakumar, MSc
Doctoral Supervisor: Prof. Aleksandra Wesołowska, PhD, DSc in Medical and Health Sciences
Project Title: Human milk as infantile Super Food - the effect of dietary choices and supplementation on the shift of lipidomic profile during different stages of lactation
Project Objectives: The objective of the project is to develop a procedure for lipid extraction from human milk, their analysis utilizing a dedicated liquid chromatography method coupled with high-resolution mass spectrometry, and the identification and semi-quantitative measurement of these molecules within the sample. This study will employ advanced techniques for lipid measurement in biological samples and will enable the establishment of a uniform procedure for sample preparation and processing. The subsequent step will involve comparing how the maternal diet influences the lipid composition status and how this profile alters over a 6-month period. These investigations will facilitate an understanding of the diet-dependent changes occurring within the highly complex and analytically challenging spectrum of breast milk lipids, while simultaneously allowing for an assessment of the extent to which diet impacts this composition. In the future, the results of this study could serve to better evaluate breast milk composition and could be utilized to develop improved infant formula products.
Principal Investigator: Mariusz Radkiewicz MSc
Doctoral Supervisor: Prof. Aleksandra Wesołowska, PhD, DSc in Medical and Health Sciences
Funding Source: This project is funded by the National Science Centre (NCN), Poland, under the PRELUDIUM grant programme (Grant No. 2024/53/N/NZ2/02675).
Project Partners: The project is carried out by the Institute of Biochemistry and Biophysics, Polish Academy of Sciences in cooperation with the Laboratory of Human Milk and Lactation Research, Medical University of Warsaw.
Project Title: Artificial Intelligence–Based Optimization of Human Milk Composition in Human Milk Banks through Donor Milk PoolingCel projektu:
Project Objective: The aim of this project is to develop a strategy for optimizing the composition of human milk stored in human milk banks through the application of artificial intelligence (AI)-based models. The project involves the analysis of retrospective data on human milk donors and milk quality parameters in order to develop a model that enables the selection and pooling of milk batches with a desired nutritional composition.
The outcomes of the project are expected to improve the efficiency of human milk bank operations in Poland and support the provision of donor milk tailored to the nutritional needs of vulnerable infants, particularly preterm newborns.
Principal Investigator: Magdalena Markiewicz, MSc
Project Supervisor: Prof. Aleksandra Wesołowska, PhD, DSc in Medical and Health Sciences
Research Team Member from the Laboratory: Aleksandra Mołas, MSc
Funding Source: The project is funded through a student research grant awarded to Magdalena Markiewicz, a Master's student in Dietetics.
Project Partners: The project is conducted in collaboration with researchers from University of Toronto and the Human Milk Bank at Holy Family Hospital.
Project Title: Implementation of human Milk hArmonised Guidelines for Infant Nutrition in Europe (IMAGINE-HMB)
Project Objective: The primary objective of the IMAGINE-HMB project is to develop harmonized, evidence-based guidelines to ensure the safety and quality of human milk donation and human milk banking practices across Europe. The initiative aims to align milk banking procedures with the enhanced requirements of the new European Union Regulation on Substances of Human Origin (SoHO Regulation, 2024).
By supporting the implementation of standardized practices, the project seeks to strengthen the quality, safety, and sustainability of human milk banking systems and improve access to safe donor human milk for infants who need it most.
Project Lead: Board of the European Milk Bank Association (EMBA)
Research Team Members from the Laboratory:
- Prof. Aleksandra Wesołowska, PhD, DSc in Medical and Health Sciences (Medical University of Warsaw Representative)
- Gabriela Olędzka, PhD, DSc in Health Sciences (Medical University of Warsaw Representative)
Funding Source: The project is funded by the European Union under Horizon Europe, the EU Framework Programme for Research and Innovation (2021–2027).