Recruiting

Virtual Reality & Linaclotide

Sponsor:

Mayo Clinic

Code:

NCT05796388

Conditions

Irritable Bowel Syndrome With Constipation

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Virtual Reality

Study Details

Brief summary:

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.

Conditions

Irritable Bowel Syndrome With Constipation

Study ID

NCT05796388

Start date

May 31, 2024

Status verified date

Jul, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

65 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: Sham VR

Patients in the sham Virtual Reality group will receive the same brand of head mounted device (Oculus Quest 2), but will only have access to sham content. Both groups will receive standard of care linaclotide treatment 290 mcg.

active comparator: Immersive VR

Patients in the immersive Virtual Reality group will receive a head mounted VR device Oculus Quest 2, and will receive active immersive content. Both groups will receive standard of care linaclotide treatment 290 mcg.

Interventions

Virtual Reality

Both groups will receive standard of care linaclotide 290 mcg.

Primary outcome measure

  • Changes in IBS symptoms [ Time Frame: End of study week 8 compared to baseline ]

Central Contacts and Locations

Central contacts

Brian Lacy, MD, PhD

904-953-6970lacy.brian@mayo.edu

Kristen Lozano

904-953-4725Lozano.Kristen@mayo.edu

Locations

Mayo Clinic Florida

Recruiting

Jacksonville, Florida, United States, 32224

More Information

Sponsor

Mayo Clinic

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

  • Virtual reality
  • IBS-C

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-07-29.