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Ear zap for IBD? tiny study tests nerve stimulation for gut relief

NCT ID NCT07636304

Knowledge-focused Sponsor: University of Gdansk Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 12, 2026 · Updated 2 times

Summary

This pilot study tests whether daily, at-home stimulation of a nerve in the ear can change brain activity in people with inflammatory bowel disease (IBD) who are in remission. Fifteen adults with Crohn's disease or ulcerative colitis will use a small device for 28 days and undergo brain scans before and after. The goal is to see if this approach is feasible and whether it affects brain networks linked to stress and emotion.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Non-invasive vagus nerve stimulation device (Nurosym)
What this could lead to
If it works, this could point toward a drug-free way to manage IBD by calming the brain-gut connection.
What could go wrong
This is a very early, small pilot study with only 15 people. It is designed to test feasibility, not effectiveness, so results may not lead to a treatment.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 15 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

May 2027

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 years and older

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 Participants must meet all of the following criteria to be eligible for participation: 1. Adults aged 18 years or older. 2. Diagnosis of inflammatory bowel disease (IBD), including Crohn's disease or ulcerative colitis. 3. Clinical remission of IBD confirmed by medical evaluation. 4. Ability to provide informed consent. 5. Ability to comply with study procedures and daily use of the stimulation device. 6. No contraindications to magnetic resonance imaging (MRI). 7. No contraindications to non-invasive vagus nerve stimulation (nVNS). Exclusion Criteria Participants meeting any of the following criteria will be excluded from the study: 1. Active inflammatory bowel disease flare or clinically significant gastrointestinal symptoms. 2. Severe or life-threatening comorbid medical conditions (e.g., active cancer). 3. Contraindications to MRI, including metallic implants, pacemaker, or severe claustrophobia. 4. Contraindications to nVNS, including significant cardiac arrhythmias, severe bradycardia, active implanted electronic medical devices, recent trigeminal neuralgia, or previous vagotomy. 5. Current pregnancy. 6. Diagnosed with severe neurological or psychiatric disorders. 7. Ongoing changes in pharmacological treatment that may affect central nervous system functioning. 8. Inability to comply with study procedures or complete study assessments.

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

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

Crohn's disease (CD) In adults Inflammatory bowel disease (Crohn's disease; ulcerative colitis) Inflammatory bowel diseases (IBD) Remission of IBD Ulcerative colitis (UC)

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Gastroenterology Department / Independent Public Healthcare Centre of the Ministry of Interior and Administration in Gdansk

    Gdansk, Pomeranian Voivodeship, 80-104, Poland

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