Combining virtual reality therapy with linaclotide for treating IBS-C
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
This study is testing if using virtual reality therapy along with a medication for constipation can help adults with IBS-C feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT05796388 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of combining immersive virtual reality therapy with linaclotide, a standard medication for Irritable Bowel Syndrome with Constipation (IBS-C). Adult patients diagnosed with IBS-C will be randomly assigned to receive either active VR therapy alongside linaclotide or sham VR therapy with linaclotide. The primary outcomes will focus on improvements in quality of life and global IBS symptoms, assessed through validated questionnaires and scales. The study seeks to determine if the combination therapy leads to statistically significant enhancements in health-related quality of life and symptom relief compared to the control group.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 who meet the Rome IV criteria for IBS-C and have a moderate impairment in health-related quality of life.
Not a fit: Patients with comorbid gastrointestinal disorders or severe psychological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life and symptom management for patients suffering from IBS-C.
How similar studies have performed: While the combination of VR therapy and medication for IBS-C is a novel approach, similar studies have shown promise in using VR for various therapeutic applications.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jacksonville, Florida
- Mayo Clinic Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Brain Lacy, MD, PhD — Mayo Clinic
- Study coordinator: Brian Lacy, MD, PhD
- Email: lacy.brian@mayo.edu
- Phone: 904-953-6970
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.