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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 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.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,333 Previous Clinical Trials
3,060,110 Total Patients Enrolled
25 Trials studying Irritable Bowel Syndrome
5,098 Patients Enrolled for Irritable Bowel Syndrome
Cedars-Sinai Medical CenterOTHER
511 Previous Clinical Trials
163,239 Total Patients Enrolled
8 Trials studying Irritable Bowel Syndrome
311 Patients Enrolled for Irritable Bowel Syndrome
AbbVieIndustry Sponsor
1,022 Previous Clinical Trials
520,114 Total Patients Enrolled
4 Trials studying Irritable Bowel Syndrome
1,046 Patients Enrolled for Irritable Bowel Syndrome

Media Library

Immersive VR Clinical Trial Eligibility Overview. Trial Name: NCT05796388 — N/A
Irritable Bowel Syndrome Research Study Groups: Immersive VR, Sham VR
Irritable Bowel Syndrome Clinical Trial 2023: Immersive VR Highlights & Side Effects. Trial Name: NCT05796388 — N/A
Immersive VR 2023 Treatment Timeline for Medical Study. Trial Name: NCT05796388 — N/A
~0 spots leftby Dec 2024
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