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A Study of Prucalopride in Breastfeeding Women With Constipation

NCT04838522 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2026-05-01

No results posted yet for this study

Summary

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

  • Chronic Idiopathic Constipation (CIC)

Interventions

OTHER

No Intervention

This is a non-interventional study.

Sponsors & Collaborators

  • UC San Diego Human Milk Research Biorepository

    collaborator UNKNOWN

  • Takeda

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

  • Study Director · UC San Diego Human Milk Research Biorepository

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-02
Primary Completion
2027-10-31
Completion
2027-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04838522 on ClinicalTrials.gov