Constipation Chronic Idiopathic study: Maralixibat
Official title Maralixibat in Patients With Cystic Fibrosis and Constipation
ClinicalTrials.gov ID: NCT06413368
What this study is testing
What is Maralixibat 9.5 MG/ML [Livmarli]?
This is an investigational liquid medicine being studied to see if it helps with chronic constipation in children with cystic fibrosis. It is designed to block the reabsorption of bile acids in the intestine, which may help increase fluid in the stool to make it softer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out if Maralixibat improves stool consistency and makes it easier to poop in children with cystic fibrosis who have chronic constipation.
- Who it's for
- Children who have cystic fibrosis and chronic constipation, defined by a Bristol Stool Scale score of 4 or less.
- What's involved
- Participants will take Maralixibat and complete questionnaires about how easy it is to poop. They will also have stool consistency recorded.
- Time commitment
- The study will involve 20 children and will last long enough to collect stool and questionnaire data, with visits scheduled as needed for monitoring and assessments.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 18
You may be able to join if
- 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...
- Stable conventional constipation medication regimen (no medication changes or dose adjustments) for at least 4 weeks prior to enrollment.
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.