Measuring prucalopride levels in breast milk of breastfeeding women with constipation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• 26-week safety and efficacy test of tenapanor for adults with chronic idiopathic constipation

  This 26-week randomized, double-blind study will test whether taking tenapanor twice daily (5, 25, or 50 mg) helps adults with chronic idiopathic constipation compared with a placebo.

  Recruiting at 109 sites Phase 3 Ardelyx · Foley, Alabama and 108 other locations · NCT07382167

• MOWOOT versus trans-anal irrigation for chronic constipation

  This project will test whether daily Intermittent Colonic Exoperistalsis (ICE) with the MOWOOT device improves bowel management for adults with refractory chronic constipation who are waiting for trans-anal irrigation.

  Recruiting usMIMA S.L. · London, London · NCT06833684

• Maralixibat for constipation in children with cystic fibrosis

  We will try maralixibat for two weeks to see if it softens stools and makes bowel movements easier in children with cystic fibrosis who still have constipation despite their usual laxatives.

  Recruiting Phase 2/3 Children's Hospital Los Angeles · Los Angeles, California · NCT06413368

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.