Virtual Reality + Linaclotide for IBS with Constipation
(IBSC-VR Trial)

Recruiting in Palo Alto (17 mi)

Overseen byBrain Lacy, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Mayo Clinic

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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 Criteria

Adults aged 18-70 with moderate to severe IBS-C, as indicated by scoring below 65 on the IBS-QOL. Participants must meet Rome IV criteria for IBS-C and have seen improvement in symptoms when previously using linaclotide. Exclusions include alcohol abuse, other GI disorders like celiac or inflammatory bowel disease, history of bowel surgery, seizure disorders, inability to understand English (as VR is in English), severe depression or opioid use.

Inclusion Criteria

My IBS significantly affects my quality of life.

I am between 18 and 70 years old and have been diagnosed with IBS-C.

Exclusion Criteria

Patients who cannot actively participate in the study for any other reason (e.g., inability to understand English as the VR program is in English only)

I am currently taking linaclotide.

I do not meet the criteria for IBS-C according to Rome IV.

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Treatment Details

Interventions

Virtual Reality (Behavioural Intervention)

Trial OverviewThe study aims to see if combining virtual reality therapy with a standard medication called linaclotide improves overall symptom relief and quality of life for those with IBS-C more than just linaclotide and placebo VR.

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: Immersive VRActive Control1 Intervention

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.

Group II: Sham VRPlacebo Group1 Intervention

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.