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Virtual Reality + Linaclotide for IBS with Constipation (IBSC-VR Trial)
N/A
Waitlist Available
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
Awards & highlights
IBSC-VR Trial 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.Check my eligibility
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.See study design
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.
IBSC-VR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in IBS symptoms
Secondary outcome measures
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 moreIBSC-VR 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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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,018 Total Patients Enrolled
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1,096 Patients Enrolled for Irritable Bowel Syndrome
Cedars-Sinai Medical CenterOTHER
499 Previous Clinical Trials
164,792 Total Patients Enrolled
8 Trials studying Irritable Bowel Syndrome
311 Patients Enrolled for Irritable Bowel Syndrome
AbbVieIndustry Sponsor
954 Previous Clinical Trials
500,979 Total Patients Enrolled
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95 Patients Enrolled for Irritable Bowel Syndrome
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking linaclotide.My IBS significantly affects my quality of life.I do not meet the criteria for IBS-C according to Rome IV.I have symptoms that suggest a physical illness.I have had surgery on my colon before.My symptoms are due to a known pelvic floor disorder.I am between 18 and 70 years old and have been diagnosed with IBS-C.I do not have other health conditions that could be confused with IBS.I regularly take opioid medications.I have a known seizure disorder.I did not feel better from my IBS-C symptoms while on linaclotide.I have taken linaclotide before and experienced side effects.
Research Study Groups:
This trial has the following groups:- Group 1: Immersive VR
- Group 2: Sham VR
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals aged 25 or over welcome to participate in this trial?
"Recruitment for this clinical trial is searching for individuals aged between 18 and 70 years."
Answered by AI
Is it possible to be enrolled in this experiment?
"Eligibility for this research study requires that participants present with IBS and are between 18 and 70 years old. The investigators aim to enrol a total of 65 patients in the trial."
Answered by AI
Are there still vacancies for participants in this clinical trial?
"Not currently. The clinical trial was launched on June 1st 2023 and remains unchanged since then; thus, it isn't actively seeking new participants at this time. Nonetheless, there are 190 other studies recruiting patients now."
Answered by AI
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