Clinical Trials

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 impairment.
• Access to a wi-fi connection.

Exclusion Criteria: 

• Patients who 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, recent or active history of any type of malignancy (excluding localized skin cancers), 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.
• 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.
• Patients who have a known seizure disorder if symptoms are thought to represent an organic disorder.
• Patients who have audio-visual impairment.
• Patients who have had prior surgery to the colon.
• Patients with symptoms representing a known pelvic floor disorder.
• If the patient is pregnant or breastfeeding.
• 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. 

Eligibility last updated 12/6/23. Questions regarding updates should be directed to the study team contact.