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New treatment option for Irritable Bowel Syndrome With Constipation
Official title A Study of Virtual Reality and Linaclotide for IBS-C
ClinicalTrials.gov ID: NCT05796388
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
You likely can't join if
- Patients will be excluded from the study if they have a comorbid disorder that may confound the diagnosis of IBS, including celiac disease...
- Patients with severe depression, defined as a score equal to or greater than two standard deviations (SDs) on the NIH PROMIS depression scale, or...
- Patients using regular doses of opioid medications will also be excluded given the often-severe impact of opioids on GI motility and potential for...
- 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,
See the full eligibility 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.