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Maralixibat for Constipation in Children with Cystic Fibrosis

This study is looking at Maralixibat (Livmarli) to help children with cystic fibrosis (CF) who also have chronic constipation. Constipation is common in CF because of how the disease affects the intestines. Maralixibat works by increasing bile acids in the colon, which can help soften stool and improve bowel movements. We are enrolling 20 children, aged 1 to 18 years, who have a confirmed diagnosis of CF and ongoing constipation despite using other treatments. The main goal is to see if Maralixibat improves stool consistency, measured by the Bristol Stool Scale, over four weeks. This study is currently unclear about its status.

Study design
This study will include 20 participants and uses a "within-subjects" design, meaning each participant will be compared to themselves before and after treatment with Maralixibat.
What's involved
You would receive Maralixibat for two weeks in addition to your current constipation medicine. You would also record stool characteristics and defecation symptoms using tools provided by the study team.
Compensation
Not stated in the trial record.
Follow-up
Stool consistency will be measured from baseline up to 4 weeks after starting the study.

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NCT06413368

Maralixibat in Patients With Cystic Fibrosis and Constipation

Recruiting
PHASE2Ages 1–18InterventionalTreatment
Children's Hospital Los Angeles
~20 participants
Updated 2026-04-21 on ClinicalTrials.gov
What's tested:Maralixibat 9.5 MG/ML [Livmarli]

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Stool Consistency Measured by the Bristol Stool Scale
Measured over baseline to 4 weeks

Conditions

Constipation Chronic Idiopathic
Cystic Fibrosis

Explore related trials

Chronic constipationCystic Fibrosis

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Jaya Punati, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital Los Angeles

Who to contact

Jaya Punati, MD
[email protected]
3233615924
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Ages 1 to 18 years.
Proven diagnosis of Cystic Fibrosis confirmed by genetic testing or sweat chloride testing.
Proven diagnosis of chronic constipation, defined as a Bristol Stool Scale (BSS) score \<3 while on a stable conventional constipation therapy regimen.
Stable conventional constipation medication regimen (no medication changes or dose adjustments) for at least 4 weeks prior to enrollment. Conventional therapy may include stool softeners, stimulant laxatives, or dietary interventions.

Exclusion

Uncontrolled fat-soluble vitamin deficiency (Vitamin A, D, E, or K).
Changes to conventional constipation medication regimen within 4 weeks prior to initiation of Maralixibat.
Adequately treated chronic constipation, defined as a Bristol Stool Scale (BSS) score \>3 on the current regimen.
Known allergy or sensitivity to Maralixibat or any study-related ingredients.
Inability or unwillingness of the participant or legal guardian/representative to provide written informed consent.

What this trial measures

  • Change in Stool Consistency Measured by the Bristol Stool Scalebaseline to 4 weeks

    Constipation is defined as a Bristol Stool Scale (BSS) score of 1-3. The primary endpoint is the proportion of participants who demonstrate improvement in stool consistency, defined as either an increase of at least 1 point on the BSS from baseline or achieving a post-treatment BSS score greater than 3. The Bristol Stool Scale (BSS) is a clinical tool used to classify stool form into seven categories, ranging from very hard to entirely liquid. It helps quantify stool consistency and is commonly used in constipation and gastrointestinal studies.