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UmbrelLACT Study: Clinical Lactation Study on the Exposure to Medicines Via Human Milk

Recruitingn/aAges 18 Years - anyFemaleUniversitaire Ziekenhuizen KU Leuven
NCT06042803 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this observational study is to determine the concentration of medicines in human milk during maternal medicine intake. The main questions it aims to answer are: * What is the concentration of maternal medicines in human milk? * What is the (estimated) intake and exposure in the breastfed infant? Participants will be asked to * fill out a questionnaire regarding medical data of the mother and child * track medication intake for 3 days * collect milk samples during 24 hours * optionally, donate 2 blood samples of the mother and give consent to one blood sample of the child * fill out a questionnaire regarding the general health of the child.

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📋 Eligibility rules (as published)
Inclusion Criteria: * For breastfeeding women * Maternal age: ≥ 18 year * Currently exclusively or partially breastfeeding (/expressing milk) at the time of milk sampling * Using medicines for any indication, with at least 5 half-lives of the medicine taken * Willing to express and collect human milk * Signed informed consent to participate and for processing their personal data * For infants * Gestational age at birth: ≥24 weeks * Parental signed informed consent to participate and for processing their personal data Exclusion Criteria: * Maternal age \<18 years * Mother of twins * Not meeting the inclusion criteria
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What it tests

  • Human milk collection
  • Optionally: maternal blood sample
  • Optionally: child blood sample
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Where

1 site
Universitaire Ziekenhuizen KU Leuven
Leuven, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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