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Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

65 Participants Needed

Virtual Reality + Linaclotide for IBS with Constipation
(IBSC-VR Trial)

Overseen ByBrian 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 GroupAll trial participants will receive the active study treatment (no placebo)

Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

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 data supports the effectiveness of the treatment Virtual Reality + Linaclotide for IBS with Constipation?

Research shows that linaclotide, a medication used in this treatment, is effective in improving symptoms of irritable bowel syndrome with constipation (IBS-C), such as bowel movement satisfaction and digestive symptoms. While there is no direct evidence for virtual reality in this context, VR has been used successfully to manage pain and anxiety in other conditions, suggesting it might help improve overall treatment experience.¹ ² ³ ⁴ ⁵

Is the combination of Virtual Reality and Linaclotide safe for humans?

Linaclotide is generally well-tolerated in adults for constipation-related conditions, but it can cause diarrhea in some people, which can be severe. There is no specific safety data available for the combination of Virtual Reality and Linaclotide, but Linaclotide alone should be used cautiously, especially in those prone to fluid imbalances.¹ ⁶ ⁷ ⁸ ⁹

How is the treatment of Virtual Reality + Linaclotide for IBS with Constipation different from other treatments?

This treatment is unique because it combines linaclotide, a drug that helps relieve constipation by increasing fluid in the intestines, with virtual reality, which may help manage pain and stress. This combination aims to address both physical and psychological aspects of IBS with constipation, offering a more comprehensive approach than traditional treatments that focus solely on physical symptoms.¹ ⁸ ⁹ ¹⁰ ¹¹

What is the purpose of this trial?

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.

Research Team

Brain Lacy, MD, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

See 10 more

Timeline

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

Treatment Details

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.

Participant Groups

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 Clinic Near You

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

Findings from Research

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]

References

1.United Statespubmed.ncbi.nlm.nih.gov

The Impact of Stool Consistency on Bowel Movement Satisfaction in Patients With IBS-C or CIC Treated With Linaclotide or Other Medications: Real-World Evidence From the CONTOR Study. [2023]

2.Englandpubmed.ncbi.nlm.nih.gov

Clinical response to linaclotide at week 4 predicts sustained response in irritable bowel syndrome with constipation and improvements in digestive and extra-digestive symptoms. [2023]

3.Englandpubmed.ncbi.nlm.nih.gov

Determining an optimal dose of linaclotide for use in Japanese patients with irritable bowel syndrome with constipation: A phase II randomized, double-blind, placebo-controlled study. [2019]

4.Englandpubmed.ncbi.nlm.nih.gov

A randomized controlled and long-term linaclotide study of irritable bowel syndrome with constipation patients in Japan. [2019]

5.United Statespubmed.ncbi.nlm.nih.gov

Continuing Medical Education Questions: May 2023. [2023]

6.Francepubmed.ncbi.nlm.nih.gov

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

7.United Statespubmed.ncbi.nlm.nih.gov

Linaclotide: a novel approach to the treatment of irritable bowel syndrome. [2017]

8.Switzerlandpubmed.ncbi.nlm.nih.gov

The Use of Linaclotide in Children with Functional Constipation or Irritable Bowel Syndrome: A Retrospective Chart Review. [2021]

9.Englandpubmed.ncbi.nlm.nih.gov

Linaclotide: a novel agent for chronic constipation and irritable bowel syndrome. [2019]