Phase 2 Study of Eluxadoline for Treating Diarrhea-Predominant Irritable Bowel Syndrome in Children Ages 6 to 17

What this Trial Is About

This research aims to explore the effects of eluxadoline in treating children aged 6 to 17 years with irritable bowel syndrome with diarrhea IBS-D. It also evaluates how the drug behaves in the body of pediatric patients and assesses its safety and tolerability. The study specifically focuses on children with IBS-D symptoms, including frequent diarrhea and abdominal pain, to better understand treatment options for this group. Participants receive one of several treatments eluxadoline oral tablets at doses of 25mg, 50mg, or 100mg taken twice daily, or a matching placebo taken twice daily. The study is randomized, double-blind, and placebo-controlled, meaning participants are assigned by chance to one of these groups without knowing which treatment they receive. Enrollment for older children aged 12 to 17 has ended, while younger children aged 6 to 11 continue to be enrolled. Participants will be involved in a 4-week treatment period during which stool consistency and abdominal pain are monitored daily using an electronic diary. The study measures changes in stool consistency, abdominal pain, bowel movement frequency, and episodes of urgency or fecal incontinence. Safety and tolerability are regularly assessed throughout the study. Researchers will compare these outcomes from the start to the end of treatment to evaluate eluxadolines effects in children with IBS-D.

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