A Study of Virtual Reality and Linaclotide for IBS-C
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Reality
DeviceBoth groups will receive standard of care linaclotide 290 mcg.
Treatment groups
65 Participants
are divided into 2 treatment groupsGroup A: Sham VRSham comparator 1 intervention
Group B: Immersive VRActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in IBS symptoms
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 ranging from 0 to 500. \< 175 for mild IBS, 175-300 for moderate IBS, and \> 300 for severe IBS.
Time frame
End of study week 8 compared to baselineSecondary outcomes
1
Measure change in quality of life, using the validated IBS-QoL
Irritable Bowel Syndrome-Quality of Life Measure (IBS-QOL) The individual responses to the 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life.
Time frame
Week 82
Measure changes in abdominal pain using the NRS
The Abdominal Pain Numeric Rating Scale (NRS) patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
Time frame
Week 83
Measure changes in bloating using the Mayo bloating questionnaire
A 40-item questionnaire to understand the daily impact of symptoms of bloating and distension
Time frame
week 84
Measure changes in psychological distress using the HADs questionnaire;
The Hospital Anxiety and Depression Scale (HADs) consists of 14 items and consists of two subscales: anxiety and depression. Each item is rated on a four-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represents 'borderline' and 0-7 'normal'
Time frame
week 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Mayo Clinic
Lead sponsor
Cedars-Sinai Medical Center
Collaborator
AbbVie
Collaborator
Ironwood Pharmaceuticals, Inc.
Collaborator
Source ClinicalTrials.gov