Randomized Controlled Trial Evaluating Trans Auricular Vagal Nerve Stimulation in Patients With Irritable Bowel Syndrome Constipation Subtype
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- West Virginia University
- Enrollment
- 80
- Locations
- 1
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Zain Sobani
Assistant Professor
West Virginia University