A Study of Virtual Reality and Linaclotide for IBS-C (IBSC-VR)

April 4, 2024 updated by: Brian Lacy, Mayo Clinic

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

  1. Evaluate changes in quality of life using the validated IBS-QoL (primary outcome);
  2. Evaluate global improvement in IBS symptoms using the validated IBS-SSS;
  3. Assess global improvement in IBS symptoms using the validated Abdominal Scoring system (11);
  4. Evaluate improvement in abdominal pain using a numerical rating system (NRS);
  5. Assess improvement in constipation using the Bristol Stool Form Scale (BSFS);
  6. Evaluate response to bloating using the validated Mayo bloating questionnaire (12);
  7. Assess response to coexisting psychological distress using the validated HADs questionnaire;
  8. Evaluate changes in work productivity using the validated WPAI.

Study Type

Interventional

Enrollment (Estimated)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Immersive VR
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.
Device: Virtual Reality
Both groups will receive standard of care linaclotide 290 mcg.
Other Names:
  • Linaclotide
Sham Comparator: Sham VR
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.
Device: Virtual Reality
Both groups will receive standard of care linaclotide 290 mcg.
Other Names:
  • Linaclotide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in IBS symptoms
Time Frame: End of study week 8 compared to baseline
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.
End of study week 8 compared to baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure change in quality of life, using the validated IBS-QoL
Time Frame: Week 8
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.
Week 8
Measure changes in abdominal pain using the NRS
Time Frame: Week 8
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'.
Week 8
Measure changes in bloating using the Mayo bloating questionnaire
Time Frame: week 8
A 40-item questionnaire to understand the daily impact of symptoms of bloating and distension
week 8
Measure changes in psychological distress using the HADs questionnaire;
Time Frame: week 8
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'
week 8
Measure changes in work productivity using the validated WPAI.
Time Frame: Week 8
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
Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

AbbVie
Cedars-Sinai Medical Center
Ironwood Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Brain Lacy, MD, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 25, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

March 21, 2023

First Submitted That Met QC Criteria

March 21, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-001316

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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