A Study of Virtual Reality and Linaclotide for IBS-C
A legfontosabb adatok
- Hol
- Jacksonville (Egyesült Államok)A helyszín megnézése
Neked szólhat?
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 70 év között vagy?
Forrás: NCT05796388: ki vehet részt
Helyszínek itt: Egyesült Államok
- Mayo Clinic FloridaJacksonville, Egyesült ÁllamokContact: Brian Lacy, MD, PhDRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Mayo Clinic
- Azonosító
- NCT05796388
- A regiszteradat frissítve
- 2026. július 29.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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
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.
Bevonási feltételek: 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.
Kizáró feltételek: 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; if they have had prior surgery to the colon,; Patients previously treated with linaclotide who reported side effects,; those currently on linaclotide (any dose),; 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; have a known seizure disorder,; if symptoms are thought to represent an organic disorder,; if symptoms represent a known pelvic floor disorder,; Patients will also be excluded from the study if they do not meet Rome IV criteria for IBS-C,; 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); and those who did not note an improvement in IBS-C symptoms in the past while on linaclotide will also be excluded.