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Maralixibat in Patients With Cystic Fibrosis and Constipation

StatusRecruiting
PhasePhase 2/3
Started
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Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 7 more changesShow less
    • Primary completion date: Jun 30, 2026 to Jun 30, 2027
    • Start date changed from estimate of Jul 1, 2024 to Apr 9, 2025
    • Primary endpoint revised
    • Eligibility criteria shortened, about 9 words
    • Study description shortened, about 266 words
    • Site details revised
    • Study title shortened, about 4 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Chronic constipation is common in children with cystic fibrosis (CF), likely due to impaired chloride channel function that reduces intestinal secretions. Standard osmotic laxatives often provide inadequate relief in this population. Maralixibat is an ileal bile acid transporter inhibitor (IBATi) that increases the amount of bile acids reaching the colon. Bile acids can enhance intestinal secretion, reduce transit time, and soften stool. This study will evaluate whether Maralixibat improves stool consistency in children with CF who experience constipation. We will enroll 20 children with CF and constipation, defined as a Bristol Stool Scale score \<4 for at least one week while on a stable laxative regimen. Each participant will receive Maralixibat for two weeks in addition to their usual laxatives. Families will record stool consistency and ease of defecation before and during treatment. The primary objective is to determine whether Maralixibat improves stool consistency to a Bristol Stool Scale score \>4. The secondary objective is to assess changes in ease of defecation using standardized questionnaires.
Trial Details
NCT Number NCT06413368
Lead Sponsor Children's Hospital Los Angeles
Conditions
(from sponsor)
Constipation Chronic Idiopathic, Cystic Fibrosis
Related terms Cystic Fibrosis
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov