A Study of Virtual Reality and Linaclotide for IBS-C

NCT05796388 | Recruiting

• 1 other identifier: 23-001316
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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

Keywords

Virtual reality; IBS-C

Outcome Measures

Primary Outcomes (1)

• Changes in IBS symptoms

  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.

  End of study week 8 compared to baseline

Secondary Outcomes (5)

• Measure change in quality of life, using the validated IBS-QoL

  Week 8

• Measure changes in abdominal pain using the NRS

  Week 8

• Measure changes in bloating using the Mayo bloating questionnaire

  week 8

• Measure changes in psychological distress using the HADs questionnaire;

  week 8

• Measure changes in work productivity using the validated WPAI.

  Week 8

Study Arms (2)

Sham VR

SHAM COMPARATOR

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.

Device: Virtual Reality

Immersive VR

ACTIVE COMPARATOR

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.

Device: Virtual Reality

Interventions

Virtual Reality DEVICE

Both groups will receive standard of care linaclotide 290 mcg.

Also known as: Linaclotide

Immersive VR; Sham VR

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Mayo Clinic: lead
• Cedars-Sinai Medical Center: collaborator
• AbbVie: collaborator
• Ironwood Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Brain Lacy, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian Lacy, MD, PhD

CONTACT

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

Kristen Lozano

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The participant or their treating provider will not know if they have been assigned to the sham VR or immersive VR program.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: There will be two groups. One will receive the sham VR the other will receive immersive VR.

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 3, 2023
• Study Start: May 31, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)