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Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children

Exploring Eluxadoline's effects on children's diarrhea-related IBS.

Recruiting
6-17 years
All
Phase 2

Study Overview: This study explores the effects of a medicine called eluxadoline on children with Irritable Bowel Syndrome with Diarrhea (IBS-D). IBS-D is a condition causing tummy pain and frequent, runny stools. The study is open for kids aged 6-11, while the older group (12-17) is no longer enrolling.

Participating kids will take eluxadoline to see how it works, how safe it is, and how their bodies handle the medicine (pharmacokinetics). Girls participating should not be pregnant and must use effective birth control during the study.

  • Duration: The study requires at least 2 months of symptoms before screening.
  • Participation: Requires regular eDiary entries to track symptoms, and several medical checkups.
  • Exclusions: Kids with certain surgeries, other bowel diseases, or no gallbladder cannot join.

For a child to join, they need a parent or guardian's consent and must be able to record their symptoms. This study helps understand how well eluxadoline works and its safety for children with IBS-D. Participation involves regular checkups and keeping a diary of symptoms.

Study details
    Irritable Bowel Syndrome

NCT03339128

AbbVie

10 October 2024

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