Trans Auricular Vagal Nerve Stimulation in Patients With IBS-C (NCT07662083) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Trans Auricular Vagal Nerve Stimulation in Patients With IBS-C
United States80 participantsStarted 2026-07
Plain-language summary
This study evaluates the efficacy and safety of transcutaneous auricular vagus nerve stimulation (ta-VNS) in adults with constipation-predominant irritable bowel syndrome (IBS-C). Participants will be randomized to receive either active or sham stimulation using a non-invasive auricular device over a 60-day period.
The primary objectives are to assess changes in symptom severity and quality of life using validated instruments, including the IBS Symptom Severity Scale (IBS-SSS) and the IBS Quality of Life questionnaire (IBS-QOL). Secondary assessments include safety and participant compliance.
This study aims to determine whether ta-VNS is an effective non-invasive therapeutic modality for improving symptoms and quality of life in patients with IBS-C.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Referred to the WVU Department of Gastroenterology and Hepatology
* Diagnosis of IBS-C
Exclusion Criteria:
* Failure of second-line therapy with secretagogues (linaclotide, lubiprostone, plecanatide, or tenapanor)
* Failure of third-line therapy with tegaserod
* Known debilitating psychiatric illness
* Cognitive impairment
* Pregnancy
* Prisoners
* Active substance use disorder
* Concurrent opioid use
* History of major gastrointestinal surgery resulting in luminal alteration
* History of vagotomy
* Secondary causes of constipation (e.g., opioid use, uncontrolled hypothyroidism, celiac disease)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in IBS Symptom Severity Scale (IBS-SSS) Score at Day 60
Timeframe: Baseline to Day 60
2
Change From Baseline in IBS Quality of Life (IBS-QOL) Total Score at Day 60