Phase
Condition
Lactose Intolerance
Colic
Gastrointestinal Diseases And Disorders
Treatment
Sham VR
Sham VR
SynerGI
Clinical Study ID
Ages > 10 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Has been diagnosed by a physician with Rome IV IBS; all subtypes will be included
Has clinically significant abdominal pain as defined as an NIH PROMIS abdominal painT-score ≥ 55 (0.5 standard deviation [SD] above the normalized population mean of
Able to read/write English (SynerGI is currently only available in English)
Owns a compatible android or iOS smartphone, or personal laptop or desktop computer (excluding tablets) to complete surveys and has access to internet and email
Exclusion
Exclusion Criteria:
Presents with a condition that interferes with VR usage, including history ofseizure, facial injury precluding safe placement of headset, significant visual orhearing impairment that impacts ability to see the VR images or follow audioinstructions
Has cognitive impairment that would affect protocol participation
Has a comorbid disorder that may confound the diagnosis of IBS, including celiacdisease, inflammatory bowel disease, autoimmune disorders that affect the GI system,history of bowel resection, HIV/AIDS, diabetes with HgA1c >=7.0, neuroendocrinetumors, microscopic colitis, eosinophilic bowel disease, acute intermittentporphyria, or any other condition that a physician believes can mimic IBS symptomsand undermine diagnostic certitude
Takes standing doses of opioid medications given the often severe impact of opioidson GI motility and potential for pharmacological visceral hyperalgesia
Previously participated in a VR clinical trial
Previously participated in talk therapy
Previously used a VR program to treat their IBS
Study Design
Study Description
Connect with a study center
Cedars-Sinai Medical Center
Los Angeles, California 90048
United StatesSite Not Available
Cedars-Sinai Medical Center
Los Angeles 5368361, California 5332921 90048
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195
United StatesSite Not Available
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