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Behavioural Intervention

IBS/VR Program (SynerGI) for Irritable Bowel Syndrome

N/A

Recruiting

Led By Anthony Lembo, MD

Research Sponsored by Anthony Lembo

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meet Rome IV criteria for IBS for any type: IBS-C, IBS-D, and IBS-M

18 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, after 4 weeks using device, after 8 weeks using device

Awards & highlights

Study Summary

"This trial will test if a special virtual reality program can help improve the quality of life for patients with irritable bowel syndrome (IBS) compared to a regular virtual reality program. It will last for

Who is the study for?

This trial is for individuals with Irritable Bowel Syndrome (IBS). Specific eligibility criteria are not provided, but typically participants would need a confirmed diagnosis of IBS and may be required to meet certain health conditions.Check my eligibility

What is being tested?

The study is testing the effectiveness of an immersive virtual reality program designed for IBS patients. It compares this program to a non-immersive VR experience over eight weeks, measuring improvements in health-related quality of life.See study design

What are the potential side effects?

While specific side effects are not listed, VR experiences can sometimes cause motion sickness or eye strain. Participants should report any discomfort they experience during the use of the VR headset.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with IBS according to Rome IV criteria.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, after 4 weeks using device, after 8 weeks using device

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, after 4 weeks using device, after 8 weeks using device

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, after 4 weeks using device, after 8 weeks using device for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

IBS-targeted HRQOL (health-related quality of life)

Secondary outcome measures

GI (Gastrointestinal) Pain Intensity

Generalized anxiety

IBS symptom severity

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: IBS/VR Program (SynerGI)Experimental Treatment1 Intervention

Group II: Sham VR ProgramPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Virtual Reality Headset

2022

N/A

~410

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterOTHER

500 Previous Clinical Trials

164,788 Total Patients Enrolled

8 Trials studying Irritable Bowel Syndrome

301 Patients Enrolled for Irritable Bowel Syndrome

Anthony LemboLead Sponsor

1 Previous Clinical Trials

340 Total Patients Enrolled

1 Trials studying Irritable Bowel Syndrome

340 Patients Enrolled for Irritable Bowel Syndrome

Anthony Lembo, MDPrincipal InvestigatorThe Cleveland Clinic

5 Previous Clinical Trials

1,256 Total Patients Enrolled

3 Trials studying Irritable Bowel Syndrome

1,059 Patients Enrolled for Irritable Bowel Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently being admitted to participate in this trial?

"According to the details on clinicaltrials.gov, this investigation is actively enrolling participants. The trial was originally uploaded on February 1st, 2024 and recently revised on February 12th of the same year."

Answered by AI

How many individuals are enrolled as participants in this ongoing medical study?

"Indeed, the details on clinicaltrials.gov affirm that this investigation is presently enrolling volunteers. This study's initial posting was noted on February 1st, 2024 and its latest update occurred on February 12th, 2024. A total of 75 individuals are sought from two distinct sites for participation in the trial."

Answered by AI