RECRUITING

A Study of Virtual Reality and Linaclotide for IBS-C

Conditions

Irritable Bowel Syndrome With Constipation Virtual reality IBS-C

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Pilot Study to Evaluate the Efficacy and Safety of Virtual Reality in Combination With Linaclotide for the Treatment of Adults With IBS and Constipation Predominance

Quick Facts

Study Start:2024-05-31

Study Completion:2024-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05796388

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Brian Lacy, MD, PhD

CONTACT

904-953-6970

lacy.brian@mayo.edu

Kristen Lozano

CONTACT

904-953-4725

Lozano.Kristen@mayo.edu

Principal Investigator

Brain Lacy, MD, PhD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic Florida

Jacksonville, Florida, 32224

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Brain Lacy, MD, PhD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-31

Study Completion Date2024-12

Study Record Updates

Study Start Date2024-05-31

Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

Virtual reality
IBS-C

Additional Relevant MeSH Terms

Irritable Bowel Syndrome With Constipation