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Could a tiny ear device tame IBS pain? new trial recruits young adults

NCT ID NCT06847360

Symptom relief Sponsor: Yale University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a small, home-use device that gently stimulates a nerve in the ear can help young adults (ages 18-29) manage pain and other symptoms of irritable bowel syndrome (IBS). Eighty participants will use either the active device or a sham (inactive) version twice daily for six weeks. The main goals are to see if the treatment is feasible, safe, and satisfactory, and to measure changes in pain, anxiety, fatigue, and quality of life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 29 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Chronic Pain chronic pain syndrome irritable bowel syndrome syndromic disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Irritable bowel syndrome Pain, chronic Symptom cluster

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06511, United States

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Other studies related to the condition(s) this trial covers.