Actively Recruiting
A Study of Virtual Reality and Linaclotide for IBS-C
Led by Mayo Clinic · Updated on 2026-01-20
65
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
C
Cedars-Sinai Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Virtual Reality and Linaclotide for IBS-C
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult men and women aged 18 to 70 years
- Meet Rome IV criteria for IBS with constipation (IBS-C)
- Score below 65 points on the IBS Quality of Life (IBS-QOL) instrument indicating moderate or worse quality of life impairment
You will not qualify if you...
- Have other medical conditions that may mimic IBS symptoms, such as celiac disease, inflammatory bowel disease, autoimmune GI disorders, history of bowel resection, HIV/AIDS, poorly controlled diabetes (HgA1c >7.0), neuroendocrine tumors, microscopic colitis, lactase deficiency, eosinophilic bowel disease, acute intermittent porphyria
- Have severe depression or suicidal thoughts
- Use regular doses of opioid medications
- Do not meet Rome IV criteria for IBS-C
- Have known seizure disorder
- Symptoms suggest organic or pelvic floor disorders
- Abuse alcohol
- Unable to participate actively (e.g., cannot understand English)
- Previously treated with linaclotide and experienced side effects
- Currently on linaclotide
- Did not improve IBS-C symptoms with prior linaclotide treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
Research Team
B
Brian Lacy, MD, PhD
CONTACT
K
Kristen Lozano
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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