Measuring prucalopride levels in breast milk of breastfeeding women with constipation
A Breast Milk Study in Lactating Women Who Have Been Prescribed Therapeutic Doses of MOTEGRITY® or RESOTRAN® (Prucalopride) for Chronic Idiopathic Constipation to Evaluate Prucalopride Concentrations in Breast Milk, and to Collect Incidental Safety Data From the Nursing Infants
This study is testing how much of the constipation medication prucalopride is found in the breast milk of breastfeeding women to see if it affects their babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Takeda Industry-sponsored |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT04838522 on ClinicalTrials.gov |
What this trial studies
This observational study aims to measure the concentration of prucalopride, a medication for constipation, in the breast milk of breastfeeding women. Participants will collect milk samples over a 24-hour period using an electric breast pump, which will then be sent to a laboratory for analysis. Additionally, the study will monitor the growth and development of infants breastfed by these women and assess any potential side effects through regular telephone interviews and questionnaires during the first year of the infant's life.
Who should consider this trial
Good fit: Ideal candidates are breastfeeding women aged 18 and older with a singleton infant between 10 days and 11 months old.
Not a fit: Patients who are not currently breastfeeding or whose infants are not within the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effects of prucalopride on breastfeeding infants.
How similar studies have performed: While studies on prucalopride exist, this specific focus on breastfeeding women and the pharmacokinetics in breast milk is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Participants cannot be enrolled before all inclusion criteria are confirmed. * Female participants with an ability to voluntarily provide verbal followed by written, signed, and dated (personally or via a legally authorized representative) informed consent as applicable to participate in the study. * Participants greater than or equal to (\>=) 18 years of age at the time of consent. This inclusion criterion will only be assessed at the time of enrollment. * Participants who are currently breastfeeding a singleton infant who is between 10 days and 11 months 0 days, inclusive. Note that participants pumping breast milk and bottle feeding their infant breast milk are allowed to participate. * Participants who are currently exclusively breastfeeding or breastfeeding with supplemental formula and/or solid food. Infants who are exclusively breastfed and do not yet eat solid food are preferred. * Participants who are currently treated as prescribed by their physician with MOTEGRITY or RESOTRAN (generic forms of prucalopride not allowed) for functional constipation, including chronic idiopathic constipation (CIC) and irritable bowel syndrome-constipation (IBS-C), for at least 5 consecutive days at the time of taking the first breastmilk sample. * Participants who agree to the conditions and requirements of the study including the sample collection, interview schedule, completion of developmental questionnaires, and release of medical records. * Participants with an understanding, ability, and willingness to fully comply with study procedures and restrictions. Exclusion Criteria: The participant will be excluded from the study if any of the following exclusion criteria are met: * Participants who are breastfeeding an infant who: is hospitalized, has a major birth defect, or has a history of a disease that could affect absorption or drug disposition. * Participants who have used MOTEGRITY or RESOTRAN while breastfeeding for a condition other than functional constipation. * Participants who are pregnant at the time of enrollment. * Participants who have started to wean their child from breast milk. * Participants with a history of any hematological, hepatic, respiratory, cardiovascular, renal, gall bladder removal, or other current or recurrent disease that could affect the action, absorption, or disposition of prucalopride.
Where this trial is running
La Jolla, California
- University of California San Diego — La Jolla, California, United States (Recruiting)
Study contacts
- Study coordinator: Takeda Contact
- Email: medinfoUS@takeda.com
- Phone: +1-877-825-3327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.