Back to resultsA Study of Virtual Reality and Linaclotide for IBS-C (IBSC-VR)
Primary Purpose
Irritable Bowel Syndrome With Constipation
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome With Constipation focused on measuring Virtual reality, IBS-C
Eligibility Criteria
Inclusion Criteria: Adult men and women (18-70) who meet Rome IV criteria for IBS-C. Patients will be required to score below 65 points on the IBS Quality of Life (IBS-QOL) instrument, indicating a score consistent with at least moderate HRQOL (Health-related quality of life) impairment. Exclusion Criteria: Patients will be excluded from the study if they have a comorbid disorder that may confound the diagnosis of IBS, including celiac disease, inflammatory bowel disease, autoimmune disorders that affect the GI system, history of bowel resection, HIV/AIDS, diabetes with HgA1c >7.0, neuroendocrine tumors, microscopic colitis, lactase deficiency, eosinophilic bowel disease, acute intermittent porphyria, or any other condition that a licensed physician believes can mimic IBS symptoms and undermine diagnostic certitude. Patients with severe depression, defined as a score equal to or greater than two standard deviations (SDs) on the NIH PROMIS depression scale, or those with suicidal ideations, will also be excluded and provided with standard resources to support their mental health and referred back to their primary care provider, a member of the study team will follow up with the PCP to ensure the communication was received. Patients using regular doses of opioid medications will also be excluded given the often-severe impact of opioids on GI motility and potential for pharmacological visceral hyperalgesia. Patients will also be excluded from the study if they do not meet Rome IV criteria for IBS-C, have a known seizure disorder, if symptoms are thought to represent an organic disorder, if they have had prior surgery to the colon, if symptoms represent a known pelvic floor disorder, if the patient is abusing alcohol, or if the patient cannot actively participate in the study for any other reason (e.g., inability to understand English as the VR program is in English only). Patients previously treated with linaclotide who reported side effects, those currently on linaclotide (any dose), and those who did not note an improvement in IBS-C symptoms in the past while on linaclotide will also be excluded.
Sites / Locations
- Mayo Clinic Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Sham VR
Immersive VR
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Changes in IBS symptoms
Measure global changes in IBS symptoms using the validated IBS severity scoring system (IBS-SSS) at week 8 compared to baseline, for patients treated with a combination of linaclotide and immersive VR and compare to those treated with linaclotide and sham VR therapy. IBS-SSS is a composite score of abdominal pain, number of days with abdominal pain, bloating/distension, satisfaction with bowel habits, and IBS-related quality of life (QoL). Each measure is rated from 0 to 100, with total scores ranging from 0 to 500. < 175 for mild IBS, 175-300 for moderate IBS, and > 300 for severe IBS.
Secondary Outcome Measures
Measure change in quality of life, using the validated IBS-QoL
Irritable Bowel Syndrome-Quality of Life Measure (IBS-QOL) The individual responses to the 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life.
Measure changes in abdominal pain using the NRS
The Abdominal Pain Numeric Rating Scale (NRS) patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
Measure changes in bloating using the Mayo bloating questionnaire
A 40-item questionnaire to understand the daily impact of symptoms of bloating and distension
Measure changes in psychological distress using the HADs questionnaire;
The Hospital Anxiety and Depression Scale (HADs) consists of 14 items and consists of two subscales: anxiety and depression. Each item is rated on a four-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represents 'borderline' and 0-7 'normal'
Measure changes in work productivity using the validated WPAI.
The Work Productivity and Activity Impairment (WPAI) questionnaire consists of six questions: 1 = currently employed; 2 = hours missed due to health problems; 3 = hours missed other reasons; 4 = hours actually worked; 5 = degree health affected productivity while working (using a 0 to 10 Visual Analogue Scale (VAS)); 6 = degree health affected productivity in regular unpaid activities
Full Information
NCT ID
NCT05796388
First Posted
March 21, 2023
Last Updated
October 13, 2023
Sponsor
Mayo Clinic
Collaborators
Cedars-Sinai Medical Center, AbbVie, Ironwood Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05796388
Brief Title
A Study of Virtual Reality and Linaclotide for IBS-C
Acronym
IBSC-VR
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Cedars-Sinai Medical Center, AbbVie, Ironwood Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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
Evaluate changes in quality of life using the validated IBS-QoL (primary outcome);
Evaluate global improvement in IBS symptoms using the validated IBS-SSS;
Assess global improvement in IBS symptoms using the validated Abdominal Scoring system (11);
Evaluate improvement in abdominal pain using a numerical rating system (NRS);
Assess improvement in constipation using the Bristol Stool Form Scale (BSFS);
Evaluate response to bloating using the validated Mayo bloating questionnaire (12);
Assess response to coexisting psychological distress using the validated HADs questionnaire;
Evaluate changes in work productivity using the validated WPAI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome With Constipation
Keywords
Virtual reality, IBS-C
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There will be two groups. One will receive the sham VR the other will receive immersive VR.
Masking
ParticipantCare Provider
Masking Description
The participant or their treating provider will not know if they have been assigned to the sham VR or immersive VR program.
Allocation
Randomized
Enrollment
65 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sham VR
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Immersive VR
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Virtual Reality
Other Intervention Name(s)
Linaclotide
Intervention Description
Both groups will receive standard of care linaclotide 290 mcg.
Primary Outcome Measure Information:
Title
Changes in IBS symptoms
Description
Measure global changes in IBS symptoms using the validated IBS severity scoring system (IBS-SSS) at week 8 compared to baseline, for patients treated with a combination of linaclotide and immersive VR and compare to those treated with linaclotide and sham VR therapy. IBS-SSS is a composite score of abdominal pain, number of days with abdominal pain, bloating/distension, satisfaction with bowel habits, and IBS-related quality of life (QoL). Each measure is rated from 0 to 100, with total scores ranging from 0 to 500. < 175 for mild IBS, 175-300 for moderate IBS, and > 300 for severe IBS.
Time Frame
End of study week 8 compared to baseline
Secondary Outcome Measure Information:
Title
Measure change in quality of life, using the validated IBS-QoL
Description
Irritable Bowel Syndrome-Quality of Life Measure (IBS-QOL) The individual responses to the 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life.
Time Frame
Week 8
Title
Measure changes in abdominal pain using the NRS
Description
The Abdominal Pain Numeric Rating Scale (NRS) patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
Time Frame
Week 8
Title
Measure changes in bloating using the Mayo bloating questionnaire
Description
A 40-item questionnaire to understand the daily impact of symptoms of bloating and distension
Time Frame
week 8
Title
Measure changes in psychological distress using the HADs questionnaire;
Description
The Hospital Anxiety and Depression Scale (HADs) consists of 14 items and consists of two subscales: anxiety and depression. Each item is rated on a four-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represents 'borderline' and 0-7 'normal'
Time Frame
week 8
Title
Measure changes in work productivity using the validated WPAI.
Description
The Work Productivity and Activity Impairment (WPAI) questionnaire consists of six questions: 1 = currently employed; 2 = hours missed due to health problems; 3 = hours missed other reasons; 4 = hours actually worked; 5 = degree health affected productivity while working (using a 0 to 10 Visual Analogue Scale (VAS)); 6 = degree health affected productivity in regular unpaid activities
Time Frame
Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult men and women (18-70) who meet Rome IV criteria for IBS-C.
Patients will be required to score below 65 points on the IBS Quality of Life (IBS-QOL) instrument, indicating a score consistent with at least moderate HRQOL (Health-related quality of life) impairment.
Exclusion Criteria:
Patients will be excluded from the study if they have a comorbid disorder that may confound the diagnosis of IBS, including celiac disease, inflammatory bowel disease, autoimmune disorders that affect the GI system, history of bowel resection, HIV/AIDS, diabetes with HgA1c >7.0, neuroendocrine tumors, microscopic colitis, lactase deficiency, eosinophilic bowel disease, acute intermittent porphyria, or any other condition that a licensed physician believes can mimic IBS symptoms and undermine diagnostic certitude.
Patients with severe depression, defined as a score equal to or greater than two standard deviations (SDs) on the NIH PROMIS depression scale, or those with suicidal ideations, will also be excluded and provided with standard resources to support their mental health and referred back to their primary care provider, a member of the study team will follow up with the PCP to ensure the communication was received.
Patients using regular doses of opioid medications will also be excluded given the often-severe impact of opioids on GI motility and potential for pharmacological visceral hyperalgesia.
Patients will also be excluded from the study if they do not meet Rome IV criteria for IBS-C,
have a known seizure disorder,
if symptoms are thought to represent an organic disorder,
if they have had prior surgery to the colon,
if symptoms represent a known pelvic floor disorder,
if the patient is abusing alcohol,
or if the patient cannot actively participate in the study for any other reason (e.g., inability to understand English as the VR program is in English only).
Patients previously treated with linaclotide who reported side effects,
those currently on linaclotide (any dose),
and those who did not note an improvement in IBS-C symptoms in the past while on linaclotide will also be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Lacy, MD, PhD
Phone
904-953-6970
Email
lacy.brian@mayo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kristen Lozano
Phone
904-953-4725
Email
Lozano.Kristen@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brain Lacy, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study of Virtual Reality and Linaclotide for IBS-C
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