A Study of Virtual Reality and Linaclotide for IBS-C
Key facts
- Where
- Jacksonville, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT05796388, who can take part
Where in United States
- Mayo Clinic FloridaJacksonville, United StatesContact: Brian Lacy, MD, PhDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Mayo Clinic
- Trial code
- NCT05796388
- Record updated
- 29 July 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; if they have had prior surgery to the colon,; Patients previously treated with linaclotide who reported side effects,; those currently on linaclotide (any dose),; 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; have a known seizure disorder,; if symptoms are thought to represent an organic disorder,; if symptoms represent a known pelvic floor disorder,; Patients will also be excluded from the study if they do not meet Rome IV criteria for IBS-C,; 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); and those who did not note an improvement in IBS-C symptoms in the past while on linaclotide will also be excluded.