Virtual Reality + Linaclotide for IBS with Constipation

(IBSC-VR Trial)

Overseen By Brian Lacy, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Opioids, Linaclotide

Disqualifiers: Celiac, IBD, Diabetes, Depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

65 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether combining immersive virtual reality (VR) therapy with the medication linaclotide can improve symptoms for people with IBS-C (irritable bowel syndrome with constipation) more effectively than using the medication with a sham (fake) VR experience. Participants will engage with either active VR content or a sham version while taking linaclotide, which already treats IBS-C. The trial seeks adults diagnosed with IBS-C who experience a moderate impact on their quality of life. As an unphased trial, this study provides a unique opportunity to explore innovative treatment combinations that could enhance the quality of life for IBS-C patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking linaclotide or have used it before with side effects or no improvement.

What prior data suggests that this virtual reality therapy is safe for IBS with constipation?

Research has shown that virtual reality (VR) treatments are generally safe and easy to manage. A study by Cedars-Sinai found that home-based VR programs helped patients with irritable bowel syndrome (IBS) manage pain without major side effects. Other studies suggest that VR can be beneficial for treating IBS and similar conditions. Although these studies don't focus solely on safety, they indicate that many patients can use VR without serious issues.

In this trial, both groups will receive linaclotide, a medication already approved for IBS with constipation (IBS-C), so its safety is well-established. Overall, evidence suggests that the VR component of this study is likely safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about combining Virtual Reality (VR) with linaclotide for IBS with constipation because it offers a unique approach that goes beyond traditional treatments. Unlike standard medications that primarily target the digestive system, VR provides a non-invasive way to potentially reduce symptoms by immersing patients in calming, virtual environments. This method could enhance the overall treatment experience, making it more engaging and possibly improving patient outcomes. Plus, the use of VR represents a novel delivery method, adding an innovative layer to the existing standard of care with linaclotide.

What evidence suggests that this trial's treatments could be effective for IBS-C?

Research has shown that virtual reality (VR) might help manage symptoms of irritable bowel syndrome with constipation (IBS-C). Some studies suggest that using VR for cognitive behavioral therapy (CBT) can improve IBS symptoms and enhance quality of life. Two recent studies also highlighted VR's potential in treating digestive issues like IBS. Although the exact mechanism of VR remains unclear, it might help by reducing stress and anxiety, which can worsen IBS symptoms. In this trial, participants will be divided into two groups: one receiving immersive VR and the other receiving sham VR. Both groups will receive standard linaclotide treatment. Early findings indicate that VR, when combined with traditional treatments like linaclotide, could offer additional benefits for people with IBS-C. ^{1 2 3 4 6}

Who Is on the Research Team?

Brain Lacy, MD, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My IBS significantly affects my quality of life.

Exclusion Criteria

Patients who cannot actively participate in the study for any other reason (e.g., inability to understand English as the VR program is in English only)

I am currently taking linaclotide.

I do not meet the criteria for IBS-C according to Rome IV.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a combination of linaclotide and either active or sham virtual reality therapy

8 weeks

Regular visits for treatment and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality

Trial Overview 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.

How Is the Trial Designed?

Group I: Immersive VR Active Control 1 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 VR Placebo Group 1 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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Cedars-Sinai Medical Center

Collaborator

Trials

523

Recruited

165,000+

AbbVie

Industry Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Ironwood Pharmaceuticals, Inc.

Industry Sponsor

Trials

42

Recruited

17,100+

Published Research Related to This Trial

Linaclotide has been shown to provide more frequent relief from constipation-related symptoms compared to a placebo in two clinical trials involving about 1600 patients, lasting 3 to 6 months.

However, it can cause significant gastrointestinal side effects, particularly diarrhea, which affected 20% of patients and led to discontinuation in about 10%, raising concerns about its safety and the lack of evidence showing it is more effective than other laxatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Linaclotide. A bacterial enterotoxin derivative with a laxative action, nothing more. [2017]

Linaclotide is a promising new treatment for irritable bowel syndrome with constipation (IBS-C) and chronic constipation, showing effectiveness in clinical trials, particularly in two Phase III studies for each condition.

The drug is well-tolerated and offers a new option for patients who do not respond well to existing treatments, although its exact position among current therapies will be determined after FDA approval.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pharmacokinetics, pharmacodynamics, clinical efficacy, safety and tolerability of linaclotide. Lee, N., Wald, A.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11401788/

The Role of Virtual Reality in the Management of Irritable ... This article explores the potential role of virtual reality (VR)-based cognitive behavioral therapy (CBT) in treating patients with IBS.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05796388

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

3. withpower.com withpower.com/trial/phase-irritable-bowel-syndrome-3-2023-4c268

Virtual Reality + Linaclotide for IBS with Constipation 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 ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06257472/efficacy-of-virtual-reality-vr-for-irritable-bowel-syndrome

Efficacy of Virtual Reality (VR) for Irritable Bowel Syndrome In this study, the investigators conduct a remote, eight-week, two-arm, randomized controlled trial that assesses the benefits, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9972609/

Virtual Reality: A New Treatment Paradigm for Disorders of ... Two recent novel studies have demonstrated that VR has the potential to play an important role in the treatment of functional dyspepsia and IBS. This article ...

6. cedars-sinai.org cedars-sinai.org/newsroom/study-virtual-reality-helps-ibs-patients/

Study: Virtual Reality Helps IBS Patients A home-based virtual reality (VR) program developed by Cedars-Sinai investigators to help patients with irritable bowel syndrome (IBS) pain received positive ...