Actively Recruiting
A Pilot Study to Evaluate the Efficacy and Safety of Virtual Reality Combined With Linaclotide for Adults With IBS and Constipation Predominance
Led by Mayo Clinic · Updated on 2026-01-20
65
Participants Needed
1
Research Sites
N/A
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
Researchers are studying adults with irritable bowel syndrome with constipation (IBS-C) to see if combining a standard medication called linaclotide with immersive virtual reality (VR) therapy improves overall IBS symptoms and quality of life compared to linaclotide with sham VR. The study focuses on patients who meet Rome IV criteria for IBS-C and aims to measure changes in symptoms like abdominal pain, constipation, bloating, psychological distress, and work productivity. Participants are randomly assigned to one of two groups: one receiving linaclotide 290 mcg plus active immersive VR content using an Oculus Quest 2 device, and the other receiving linaclotide plus sham VR content on the same device. The study treatment lasts for 8 weeks, during which patients use the VR therapy alongside their medication. During the study, participants will be assessed for changes in IBS symptoms, quality of life, abdominal pain, bloating, psychological distress, and work productivity using validated questionnaires and rating scales. These measurements are taken at baseline and again at the end of 8 weeks. The trial is double-blinded and randomized to ensure unbiased results. The total participation period covers the 8-week treatment and evaluation timeframe.
CONDITIONS
Brief 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
- Diagnosis of IBS with constipation (IBS-C) according to Rome IV criteria
- IBS Quality of Life score below 65, indicating at least moderate impairment in quality of life
You will not qualify if you...
- Presence of other gastrointestinal or autoimmune disorders that could affect IBS diagnosis, such as celiac disease, inflammatory bowel disease, neuroendocrine tumors, microscopic colitis, eosinophilic bowel disease
- History of bowel resection or colon surgery
- Severe depression or suicidal ideation
- Regular use of opioid medications
- Known seizure disorder or organic disorders mimicking IBS
- Known pelvic floor disorder
- Alcohol abuse
- Inability to participate due to language barriers or other reasons
- Previous treatment with linaclotide that caused side effects or no symptom improvement
- Current use of linaclotide or lack of past improvement with linaclotide treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive linaclotide daily along with either active immersive virtual reality or sham virtual reality content.
Weekly visits for up to 8 weeks
Trial Site Locations
Total: 1 location
1
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
Research Team
B
Brian Lacy, MD, PhD
K
Kristen Lozano
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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