Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-24 @ 5:29 PM
NCT ID:
NCT06413368
Eligibility Criteria:
Inclusion Criteria:
* Age between 1-18 years Proven diagnosis of Cystic Fibrosis (via genetic testing or sweat chloride testing) Proven diagnosis of Chronic constipation (Bristol stool scale rating of \< 3 while on stable conventional therapy regimen) On stable (no medication changes or dose adjustments) conventional constipation medication regimen for chronic constipation (stool softeners, stimulant laxatives, dietary interventions) for at least 4 weeks.
Exclusion Criteria:
* The following are exclusion criteria for our study. All candidates meeting any of the exclusion criteria at baseline will be excluded from study participation:
Uncontrolled fat-soluble vitamin deficiency (Vitamin A, E, D, or K) Changes to conventional constipation medication regimen \<4 weeks prior to initiation of Maralixibat Adequately treated chronic constipation on conventional regimen (Bristol stool scale rating of \> 3) Allergy or sensitivity to the study drugs or their ingredients Inability or unwillingness of individual or legal guardian/representative to given written informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
18 Years
Study:
NCT06413368
Study Brief:
Protocol Section:
NCT06413368