Home-based ear (taVNS) stimulation for IBS pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a pilot randomized, parallel two‑arm trial enrolling 80 young adults (18–29) with provider‑confirmed Rome IV IBS and recurring moderate pain. After a two‑week baseline run‑in, participants are randomized to Active or Sham transcutaneous auricular vagus nerve stimulation (taVNS) delivered at home twice daily for 30 minutes over six weeks, with in‑person setup and end‑of‑treatment visits and a further six‑week follow‑up. Investigators will measure feasibility (recruitment, adherence, barriers), safety, satisfaction, and patient‑reported pain and symptom outcomes. The intervention is delivered alongside usual care and self‑management education to capture real‑world acceptability and implementation issues.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 18 - 29 years of age;
* Men and women;
* Diagnosis of IBS from a healthcare provider with current report of pain (volunteers asked to bring provider-verification of IBS diagnosis based on Rome IV criteria to initial study appointment);
* Experiencing moderate pain (≥3 out of 10 on numeric rating scale \[NRS\]) at least 4 days of the week and lasting previous three months;
* Daily access to a computer connected to the internet; and
* Able to read and speak English.

Exclusion Criteria:

* Other chronic pain condition;
* Celiac disease or inflammatory bowel disease;
* Diabetes mellitus;
* severe psychiatric condition requiring inpatient treatment in previous 6 months;
* Pregnancy or lactation;
* Regular use of opioids or other illicit substances;
* use of probiotics or antibiotics within 2 weeks from enrollment; and
* any other conditions/contraindications that prohibit the application of taVNS including but not limited to any current or past history of cardiovascular disorders, recent ear trauma, and metal implants above the level of the neck.

Where it's running

• Yale University
  New Haven, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Xiaomei S Cong — Yale University
• Study coordinator: Xiaomei S Cong, PhD
• Email: xiaomei.cong@yale.edu
• Phone: 8606179849

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.