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

N/A

Recruiting

Led By Brain Lacy, MD, PhD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 8

Summary

This trial tests how well a combo of medicine and VR therapy helps relieve IBS symptoms and improve quality of life.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Linaclotide may cause side effects such as diarrhea, gas, bloating, abdominal pain, headache, and fatigue. The virtual reality intervention is not expected to have physical side effects but could potentially cause discomfort due to its immersive nature.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in IBS symptoms

Secondary study objectives

Measure change in quality of life, using the validated IBS-QoL

Measure changes in abdominal pain using the NRS

Measure changes in bloating using the Mayo bloating questionnaire

+2 more

Trial Design

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.

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