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NCT05796388 · ClinicalTrials.gov registry record · NA
A Study of Virtual Reality and Linaclotide for IBS-C
A NA study of Irritable Bowel Syndrome With Constipation, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- NA
- Development phase
- 65
- Enrollment target
- 1
- Study location
NCT05796388: Recruiting NA study of Irritable Bowel Syndrome With Constipation, sponsored by Mayo Clinic.
NCT05796388 is a NA study of Irritable Bowel Syndrome With Constipation that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 65 participants, below the 191-participant average among 3 other Irritable Bowel Syndrome With Constipation trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05796388, a NA study of Irritable Bowel Syndrome With Constipation, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- NA
- Development phase
- 65 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Measure global changes in IBS symptoms using the validated IBS severity scoring system (IBS-SSS) at week 8 compared to baseline, for patients treated with a combination of linaclotide and immersive VR and compare to those treated with linaclotide and sham VR therapy. IBS-SSS is a composite score of abdominal pain, number of days with abdominal pain, bloating/distension, satisfaction with bowel habits, and IBS-related quality of life (QoL). Each measure is rated from 0 to 100, with total scores r
Conditions Studied
Interventions
- DEVICE Virtual Reality
Study Locations (1)
Florida
- Mayo Clinic Florida - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2024-05-31 |
| Est. Completion | 2026-06 |
| Phase | NA |
What NCT05796388 shows while recruiting
NCT05796388 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 191-participant average among 3 other Irritable Bowel Syndrome With Constipation trials with a reported enrollment target (66% lower).
The record links to 1 condition, with Irritable Bowel Syndrome With Constipation appearing as the primary indexed condition, and to 1 intervention - of which Virtual Reality is the first listed.
NCT05796388 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05796388 about?
NCT05796388 is a clinical study titled "A Study of Virtual Reality and Linaclotide for IBS-C". 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...
What is the current status of trial NCT05796388?
This trial is currently recruiting. It is a NA study. The enrollment target is 65 participants. The study started on 2024-05-31. Estimated completion is 2026-06.
What conditions does trial NCT05796388 study?
This clinical trial studies the following conditions: Irritable Bowel Syndrome With Constipation.
What interventions are being tested in trial NCT05796388?
The interventions under investigation include: Virtual Reality (DEVICE).
Who is sponsoring clinical trial NCT05796388?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05796388 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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