NCT05796388 · Mayo Clinic
A Study of Virtual Reality and Linaclotide for IBS-C
(IBSC-VR)
What this study 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 (the usual treatment medication) and immersive virtual reality (VR) therapy compared to those treated with linaclotide and sham (placebo) VR therapy.
View original scientific 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.
Interventions
DEVICE
Virtual Reality
Both groups will receive standard of care linaclotide 290 mcg.
Primary outcome measures
Changes in IBS symptoms
Time frame: End of study week 8 compared to baseline
Measure global changes in IBS symptoms using the validated IBS severity scoring system (IBS-SSS) at week 8 compared to baseline, for patients treated with a combination of linaclotide and immersive VR and compare to those treated with linaclotide and sham VR therapy. IBS-SSS is a composite score of abdominal pain, number of days with abdominal pain, bloating/distension, satisfaction with bowel habits, and IBS-related quality of life (QoL). Each measure is rated from 0 to 100, with total scores ranging from 0 to 500. \< 175 for mild IBS, 175-300 for moderate IBS, and \> 300 for severe IBS.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Jacksonville, Florida
Collaborators
Cedars-Sinai Medical Center, AbbVie, Ironwood Pharmaceuticals, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 20, 2026 · Source of record for eligibility and locations