Who may be eligible for this chronic idiopathic constipation clinical trial?

Women aged 18 or older who are currently breastfeeding a single infant between 10 days and 11 months old may be eligible. Participants must be treated with MOTEGRITY or RESOTRAN for constipation and not be pregnant. Please review eligibility criteria for more details.

Is there any cost to participate in this chronic idiopathic constipation clinical trial?

Study-related care, including all trial visits and procedures, is provided at no cost. However, any personal travel or other expenses may vary and are not guaranteed to be reimbursed.

Actively Recruiting

Age: 18Years +

FEMALE

ID04838522

Study of Prucalopride in Breastfeeding Women with Chronic Idiopathic Constipation to Measure Drug Levels in Breast Milk and Monitor Infant Safety and Development

Q: What is this study of prucalopride in breastfeeding women with chronic idiopathic constipation trying to find out?

This study is measuring the amount of prucalopride that passes into breast milk and monitoring the growth and development of babies who are breastfed by mothers taking the medication. Researchers aim to understand any potential effects on infants. The study is sponsored by Takeda and focuses on mothers treated for constipation.

Led by Takeda · Updated on 2026-05-01

Participants Needed

Research Sites

N/A

Total Duration

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 babys 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 infants 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

Age: 18Years +

FEMALE

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

Research Team

Takeda Contact

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