Actively Recruiting
A Breast Milk Study in Lactating Women Prescribed MOTEGRITY or RESOTRAN (Prucalopride) for Chronic Idiopathic Constipation Evaluating Prucalopride Levels in Breast Milk and Infant Safety
Led by Takeda · Updated on 2026-05-01
12
Participants Needed
1
Research Sites
N/A
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
Researchers are studying prucalopride, a medicine used to treat chronic idiopathic constipation (CIC), in breastfeeding women. The study aims to measure how much prucalopride passes into breast milk and to monitor the growth, development, and possible side effects in the babies who are breastfed by mothers taking this medication. Participants must be women treated with prucalopride for functional constipation and breastfeeding their infants. Participants will provide one set of breast milk samples collected over 24 hours using an electric breast pump at home. These samples will be sent to the laboratory for analysis. The study observes participants who have been prescribed prucalopride tablets under medical supervision before joining and who continue breastfeeding during sample collection. During the baby's first year, researchers will conduct telephone interviews every two months to ask questions about the baby and will ask participants to complete questionnaires assessing their infant's growth and neurodevelopment. The study will measure prucalopride levels in milk at various times after dosing and track infant growth changes, developmental milestones, and any reported adverse effects up to one year of age.
CONDITIONS
Brief Title
A Study of Prucalopride in Breastfeeding Women With Constipation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants able to give informed consent
- Aged 18 years or older at consent
- Currently breastfeeding a single infant aged between 10 days and 11 months
- Breastfeeding exclusively or with supplemental formula and/or solid food
- Treated with MOTEGRITY or RESOTRAN for functional constipation for at least 5 consecutive days before first milk sample
- Agree to study requirements including sample collection, interviews, questionnaires, and medical record release
- Able and willing to comply 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 drug absorption or disposition
- Using MOTEGRITY or RESOTRAN for conditions other than functional constipation while breastfeeding
- Pregnant at enrollment
- Started weaning the infant from breast milk
- History of hematological, liver, respiratory, heart, kidney, gall bladder removal, or other diseases affecting prucalopride action or absorption
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants who are already treated with prucalopride and breastfeeding their infants are observed prospectively with sample collection, interviews, and questionnaires to evaluate prucalopride levels in breast milk and infant safety.
1 visit on Day 1 for milk sample collection and multiple follow-up interviews and assessments up to 1 year
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
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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