Can virtual reality soothe IBS symptoms?
NCT ID NCT05796388
First seen Jun 26, 2026 · Last updated Jul 30, 2026 · Updated 3 times
Summary
This pilot study tests whether adding immersive virtual reality therapy to the standard IBS medication linaclotide can improve symptoms and quality of life more than medication alone. Researchers will enroll 65 adults with IBS-C and compare those getting real VR therapy to those getting a sham VR. The main goal is to see if the combination leads to greater symptom relief after 8 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- linaclotide and virtual reality therapy
- What this could lead to
- If it works, this could point toward a drug-free add-on therapy to ease IBS symptoms and improve quality of life.
- What could go wrong
- This is a small, early pilot study with only 65 people. The VR therapy may not provide extra benefit over medication alone, and results may not apply to everyone with IBS-C.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 65 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mayo Clinic Florida
RECRUITINGJacksonville, Florida, 32224, United States
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