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A Study of Virtual Reality and Linaclotide for IBS-C

NCT05796388 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2026-01-20

No results posted yet for this study

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

Interventions

DEVICE

Virtual Reality

Both groups will receive standard of care linaclotide 290 mcg.

Sponsors & Collaborators

  • Cedars-Sinai Medical Center

    collaborator OTHER

  • AbbVie

    collaborator INDUSTRY

  • Ironwood Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Brain Lacy, MD, PhD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-31
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05796388 on ClinicalTrials.gov