Combining virtual reality therapy with linaclotide for treating IBS-C

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of combining immersive virtual reality therapy with linaclotide, a standard medication for Irritable Bowel Syndrome with Constipation (IBS-C). Adult patients diagnosed with IBS-C will be randomly assigned to receive either active VR therapy alongside linaclotide or sham VR therapy with linaclotide. The primary outcomes will focus on improvements in quality of life and global IBS symptoms, assessed through validated questionnaires and scales. The study seeks to determine if the combination therapy leads to statistically significant enhancements in health-related quality of life and symptom relief compared to the control group.

Why it matters

Who can join: the full rules

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.

Where it's running

• Mayo Clinic Florida
  Jacksonville, Florida, United States Recruiting

Study contacts

• Principal investigator: Brain Lacy, MD, PhD — Mayo Clinic
• Study coordinator: Brian Lacy, MD, PhD
• Email: lacy.brian@mayo.edu
• Phone: 904-953-6970

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.