A Study of Virtual Reality and Linaclotide for IBS-C
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Irritable Bowel Syndrome With Constipation
In brief
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.
Key facts
- Study ID
- NCT05796388
- Run by
- Mayo Clinic
- People needed
- 65
- Starts
- 2024-05-31
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2026-07-29
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- Mayo Clinic Florida — Jacksonville, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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