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NCT05796388

A Study of Virtual Reality and Linaclotide for IBS-C

Recruiting
NAAges 18–70InterventionalTreatment
Mayo Clinic
~65 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:Virtual Reality

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in IBS symptoms
Measured over End of study week 8 compared to baseline

Conditions

Irritable Bowel Syndrome With Constipation

Explore related trials

Irritable Bowel Syndrome

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Brain Lacy, MD, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Brian Lacy, MD, PhD
[email protected]
904-953-6970
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Eligibility criteria

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 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.

What this trial measures

  • Changes in IBS symptomsEnd 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.