Virtual Reality + Linaclotide for IBS with Constipation
(IBSC-VR Trial)
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.12345
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.16789
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.1891011
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a combination of linaclotide and either active or sham virtual reality therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Virtual Reality
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Cedars-Sinai Medical Center
Collaborator
AbbVie
Industry Sponsor
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