A Study of Virtual Reality and Linaclotide for IBS-C

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT05796388
Status
Recruiting
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Conditions

  • Irritable Bowel Syndrome With Constipation

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Virtual Reality — DEVICE
    Both groups will receive standard of care linaclotide 290 mcg.

Study Details

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 Dates

Start date
May 31, 2024
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
65 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic FloridaJacksonvilleFlorida32224-

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Mayo Clinic Florida· Jacksonville, FL

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