NCT05796388

A Study of Virtual Reality and Linaclotide for IBS-C

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary aim of this study will be to assess the benefits of disease-targeted VR combined with linaclotide, compared to sham VR combined with linaclotide, in patients with IBS-C as defined by Rome IV criteria. The investigators hypothesize that compared to patients receiving sham VR and linaclotide, IBS-C patients receiving combination therapy with active VR and linaclotide will achieve statistically significant and clinically meaningful improvements in disease-targeted health-related quality of life while demonstrating improvements in global IBS symptoms, including abdominal pain. Aims 1. Evaluate changes in quality of life using the validated IBS-QoL (primary outcome); 2. Evaluate global improvement in IBS symptoms using the validated IBS-SSS; 3. Assess global improvement in IBS symptoms using the validated Abdominal Scoring system (11); 4. Evaluate improvement in abdominal pain using a numerical rating system (NRS); 5. Assess improvement in constipation using the Bristol Stool Form Scale (BSFS); 6. Evaluate response to bloating using the validated Mayo bloating questionnaire (12); 7. Assess response to coexisting psychological distress using the validated HADs questionnaire; 8. Evaluate changes in work productivity using the validated WPAI.

Conditions

• Irritable Bowel Syndrome With Constipation

Interventions

Type	Name	Description
DEVICE	Virtual Reality	Both groups will receive standard of care linaclotide 290 mcg.

Timeline

• Start date: 2024-05-31
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2023-04-03
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States