Actively Recruiting
A Study of Prucalopride in Breastfeeding Women With Constipation
Led by Takeda · Updated on 2026-05-01
12
Participants Needed
1
Research Sites
295 weeks
Total Duration
On this page
Sponsors
T
Takeda
Lead Sponsor
U
UC San Diego Human Milk Research Biorepository
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Prucalopride in Breastfeeding Women With Constipation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants able to provide informed consent.
- Participants aged 18 years or older at enrollment.
- Currently breastfeeding a single infant aged between 10 days and 11 months.
- Exclusively breastfeeding or breastfeeding with supplemental formula and/or solid food; exclusively breastfed infants preferred.
- Currently prescribed MOTEGRITY or RESOTRAN (prucalopride) for functional constipation for at least 5 consecutive days at first milk sample collection.
- Agree to study requirements including sample collection, interviews, questionnaires, and medical record release.
- Willing and able to comply fully with study procedures and restrictions.
You will not qualify if you...
- Breastfeeding an infant who is hospitalized, has a major birth defect, or a disease affecting absorption or drug disposition.
- Using MOTEGRITY or RESOTRAN while breastfeeding for conditions other than functional constipation.
- Pregnant at the time of enrollment.
- Has begun weaning the child from breast milk.
- History of hematological, hepatic, respiratory, cardiovascular, renal, gall bladder removal, or other diseases affecting prucalopride action or absorption.
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of California San Diego
La Jolla, California, United States, 92093
Actively Recruiting
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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