Clinical trial NCT05796388: A Study of Virtual Reality and Linaclotide for IBS-C
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Irritable Bowel Syndrome with Constipation
Keywords: Virtual reality
IBS-C
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Cedars-Sinai Medical Center
name: AbbVie
name: Ironwood Pharmaceuticals, Inc.
First posted: 2023-04-03
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be two groups. One will receive the sham VR the other will receive immersive VR.
Primary purpose: TREATMENT

Brief 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.

Detailed description: The primary aim of this study will be to assess the benefits of disease-targeted VR combined with linaclotide, compared to sham VR combined with linaclotide, in patients with IBS-C as defined by Rome IV criteria. The investigators hypothesize that compared to patients receiving sham VR and linaclotide, IBS-C patients receiving combination therapy with active VR and linaclotide will achieve statistically significant and clinically meaningful improvements in disease-targeted health-related quality of life while demonstrating improvements in global IBS symptoms, including abdominal pain.

Aims

1. Evaluate changes in quality of life using the validated IBS-QoL (primary outcome);
2. Evaluate global improvement in IBS symptoms using the validated IBS-SSS;
3. Assess global improvement in IBS symptoms using the validated Abdominal Scoring system (11);
4. Evaluate improvement in abdominal pain using a numerical rating system (NRS);
5. Assess improvement in constipation using the Bristol Stool Form Scale (BSFS);
6. Evaluate response to bloating using the validated Mayo bloating questionnaire (12);
7. Assess response to coexisting psychological distress using the validated HADs questionnaire;
8. Evaluate changes in work productivity using the validated WPAI.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in IBS symptoms
timeFrame: End of study week 8 compared to baseline
Secondary outcomes:
measure: Measure change in quality of life, using the validated IBS-QoL
timeFrame: Week 8
measure: Measure changes in abdominal pain using the NRS
timeFrame: Week 8
measure: Measure changes in bloating using the Mayo bloating questionnaire
timeFrame: week 8
measure: Measure changes in psychological distress using the HADs questionnaire;
timeFrame: week 8
measure: Measure changes in work productivity using the validated WPAI.
timeFrame: Week 8
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Brain Lacy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: