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RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Virtual Reality for Irritable Bowel Syndrome With Constipation

This study wants 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 (dummy treatment (placebo)) VR therapy.

Official registry: https://clinicaltrials.gov/study/NCT05796388 · Mayo Clinic · enrollment listed as 65

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Virtual Reality. The registry lists allocation as randomized. This study wants 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 (dummy treatment (placebo)) VR therapy.

They plan to enroll about 65 people at Jacksonville. Taking part typically means using or being fitted with a device plus check-ins.

Official title (unrewritten)

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

Interventions: Virtual Reality

Primary outcome (registry wording): Changes in IBS symptoms

Who it is for (from inclusion criteria)

  • Ages 18 Years to 70 Years
  • 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

Public study contact (from the registry)

Brian Lacy, MD, PhD

904-953-6970

lacy.brian@mayo.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Related recruiting trials in this snapshot

FAQ about this NCT record

Is NCT05796388 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05796388?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05796388?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

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