Evaluating Virtual Reality with Linaclotide for Adults Aged 18-70 with IBS and Constipation

What this Trial Is About

Researchers are evaluating whether adults with irritable bowel syndrome with constipation IBS-C experience better symptom relief and quality of life improvements when treated with a combination of linaclotide, a standard medication, and immersive virtual reality VR therapy compared to linaclotide combined with sham VR therapy. The study focuses on adults aged 18 to 70 who meet Rome IV criteria for IBS-C, aiming to assess effects on abdominal pain, constipation, bloating, psychological distress, and work productivity. Participants will be randomly assigned to one of two groups. Both groups will receive linaclotide 290 mcg as standard care. One group will use an Oculus Quest 2 VR headset with active immersive content designed to target IBS symptoms, while the other group will use the same device but only access sham VR content. The study is conducted in parallel groups with double blinding to compare the benefits of the active VR combined with linaclotide against the sham VR plus linaclotide. During the 8-week study period, participants will be monitored for changes in IBS symptoms, quality of life, abdominal pain, bloating, psychological distress, and work productivity using validated questionnaires and rating scales. Researchers will collect data at baseline and at the end of week 8 to evaluate treatment effects. The Mayo Clinic sponsors the study, which emphasizes careful monitoring and assessment to understand the combined impact of VR therapy and linaclotide on IBS-C.

A Study of Virtual Reality and Linaclotide for IBS-C