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

Recruiting now

Conditions studied: Breast Feeding, Human Milk

In brief

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.

Key facts

Study ID

NCT06042803

Run by

Universitaire Ziekenhuizen KU Leuven

People needed

30

Starts

2023-02-01

Expected to finish

2027-02-01

Last updated by the study team

2025-02-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Maternal age <18 years
• Mother of twins
• Not meeting the inclusion criteria

Where it is running

• Universitaire Ziekenhuizen KU Leuven — Leuven, Vlaams-Brabant, Belgium (enrolling)

Full record on ClinicalTrials.gov

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