Prucalopride is a medicine used to treat constipation. The main aim of the study is to measure prucalopride concentrations in breast milk. Other aims are to check the growth and development of babies breastfed by their mothers who took prucalopride and to check if the babies had any side effects. During the study, participants will provide one set of milk samples over 24 hours using an electric breast pump. Breast milk samples will be collected at home and will be shipped to the laboratory. Also, participants will be asked questions during telephone interviews every 2 months in the first year of their baby's life. They will also be asked to complete growth and development questionnaires about their baby.
Age range
18 Years
Sex
FEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Dose- Normalized Area Under the Milk Concentration-time Curve of Prucalopride (AUC [milk, norm])
Timeframe: Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 1
Dose- Normalized Average Concentration of Prucalopride in Milk (C [ave, milk, norm])
Timeframe: Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 1
Time Interval Over Which the AUC [milk, norm] Measured (T)
Timeframe: Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 1
Dose-normalized Daily Infant Dosage (DID [norm])
Timeframe: Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose
Percentage of Maternal Dose or Relative Infant Dose (RID [%])
Timeframe: Up to 24 hours post-dose