A Pilot Study to Evaluate the Efficacy and Safety of Virtual Reality in Combination with Linaclotide for the Treatment of Adults with IBS and Constipation Predominance
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this study is to determine if adult patients with IBS-C will report an overall greater improvement in IBS symptoms and quality of life when treated with a combination of linaclotide (standard of care medication) and immersive virtual reality (VR) therapy compared to those treated with linaclotide and sham (placebo) VR therapy.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Adult men and women (18-70) who meet Rome IV criteria for IBS-C.
• Patients will be required to score below 65 points on the IBS Quality of Life (IBS-QOL) instrument, indicating a score consistent with at least moderate HRQOL (Health-related quality of life) impairment.
Locations
United States
Florida
Mayo Clinic Florida
RECRUITING
Jacksonville
Contact Information
Primary
Brian Lacy, MD, PhD
lacy.brian@mayo.edu
904-953-6970
Backup
Kristen Lozano
Lozano.Kristen@mayo.edu
904-953-4725
Time Frame
Start Date: 2024-05-31
Estimated Completion Date: 2025-12
Participants
Target number of participants: 65
Treatments
Sham_comparator: Sham VR
Patients in the sham Virtual Reality group will receive the same brand of head mounted device (Oculus Quest 2), but will only have access to sham content. Both groups will receive standard of care linaclotide treatment 290 mcg.
Active_comparator: Immersive VR
Patients in the immersive Virtual Reality group will receive a head mounted VR device Oculus Quest 2, and will receive active immersive content. Both groups will receive standard of care linaclotide treatment 290 mcg.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic
Collaborators: Cedars-Sinai Medical Center, AbbVie, Ironwood Pharmaceuticals, Inc.