Chronic Idiopathic Constipation (CIC)
Conditions
Keywords
Prucalopride, Motegrity, Pharmacokinetics, Lactation, Breastfeeding, Milk-only study, Infant growth and development, Infant neurodevelopment, Infant outcomes
Brief 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.
Interventions
OTHERNo Intervention
This is a non-interventional study.
Sponsors
Takeda
UC San Diego Human Milk Research Biorepository
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose- Normalized Area Under the Milk Concentration-time Curve of Prucalopride (AUC [milk, norm]) | Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 1 | AUC \[milk, norm\] will be derived from a series of 7 timed, full expression breast milk samples collected from a single breast using an electric breast pump over a 24-hour period of milk collection after a dose following at least 5 consecutive daily doses. AUC \[milk, norm\] will be normalized to 2-milligrams (mg) daily maternal dose. |
| Dose- Normalized Average Concentration of Prucalopride in Milk (C [ave, milk, norm]) | Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 1 | C \[ave, milk, norm\] will be derived from a series of 7 timed, full expression breast milk samples collected from a single breast using an electric breast pump over a 24-hour period of milk collection after a dose following at least 5 consecutive daily doses. C \[ave, milk, norm\] will be normalized to 2-mg daily maternal dose. |
| Time Interval Over Which the AUC [milk, norm] Measured (T) | Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 1 | Time interval over which the AUC \[milk, norm\] is measured (T) will be reported. |
| Dose-normalized Daily Infant Dosage (DID [norm]) | Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose | DID \[norm\] will be the estimated daily infant dose received by the infant through breastfeeding. DID \[norm\] will be normalized to 2-mg daily maternal dose. |
| Percentage of Maternal Dose or Relative Infant Dose (RID [%]) | Up to 24 hours post-dose | RID \[%\]will be calculated as DID \[norm\] divided by (2 mg/day/maternal body weight (kg)) then multiplied by 100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Infants With Adverse Events (AEs) Based on Maternal Report | Up to 1 year of age | Number of infants with AEs while being breastfed by a mother who is taking prucalopride will be obtained by maternal report (by phone). |
| Change in Length During the First Year of Life in Infant's | At 6 and 12 months of age | Growth changes in length in centimeters every 2 months during the first year of life in infant's breastfed by mothers taking prucalopride will be obtained by maternal report (by phone), and medical records abstraction. |
| Change in Weight During the First Year of Life in Infant's | At 6 and 12 months of age | Growth changes in weight in grams every 2 months during the first year of life in infant's breastfed by mothers taking prucalopride will be obtained by maternal report (by phone), and medical records abstraction. |
| Change in Head Circumference During the First Year of Infant's Life | At 6 and 12 months of age | Change in head circumference at 6 and 12 months will be reported. |
| Infant's Neurodevelopmental Performance Based on Ages and Stages Questionnaire-3 (ASQ-3) | Up to 1 year of age | Infant's neurodevelopmental progress at 12 months will be assessed by the ASQ-3 which will be completed by the mother. The ASQ-3 is a developmental screening instrument with 5 domains: (i) personal-social, (ii) gross motor, (iii) fine motor, (iv) problem solving, and (v) communication. All domains will be evaluated both continuously and categorically, with 3 categories: normal, borderline, abnormal. Abnormal scores of clinical concern are defined by test-based, standardized scoring criteria reported in the ASQ-3 User's Guide; these represent scores that are \<2.0 SDs below the mean for each category. Borderline scores are scores that fall between 2.0 and 1.5 SDs below the mean. Each domain has 6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0. ASQ-3 average = average score of 5 aspects. |
Countries
United States
Contacts
CONTACTTakeda Contact
STUDY_DIRECTORStudy Director
Takeda
Outcome results
None listed