Trans Auricular Vagal Nerve Stimulation in Patients With IBS-C
ConditionIrritable Bowel Syndrome (IBS-C)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWest Virginia University
About this trial
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.
Eligibility criteria
Qualifiers
Referred to the WVU Department of Gastroenterology and Hepatology
Diagnosis of IBS-C
Disqualifiers
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
Trial design
Treatments tested in this trial
- Transcutaneous Auricular Vagus Nerve Stimulation (ta-VNS)
- Sham Transcutaneous Auricular Vagus Nerve Stimulation
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov