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Could a tiny ear device tame IBS?

NCT ID NCT02420158

Symptom relief Sponsor: Hospices Civils de Lyon 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This small pilot study tested a device that gently stimulates the vagus nerve through the skin in women with irritable bowel syndrome (IBS). Over six months, researchers measured changes in digestion, inflammation, symptoms, and quality of life. The goal was to see if this non-invasive approach is safe and can help ease IBS symptoms.

What this could mean

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

Active substance
transcutaneous vagal nerve electrical stimulation device
What this could lead to
If it works, this could point toward a drug-free way to ease IBS symptoms and improve quality of life.
What could go wrong
This is a very small pilot study with only 10 women, so results may not apply to everyone. The device may cause side effects or fail to improve symptoms.

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

18 people

The number who actually took part.

Started

May 2015

Finished

Aug 2018

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 60 years

Sex

Female participants only

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: * women aged 18-60, * clinical Rome III criteria for IBS Exclusion Criteria: * pregnancy, * low intensity symptoms (Francis score between 75-150) * IBD, coeliac disease * past history of abdominal surgery (appendectomy and cholecystectomy allowed) * chronic use of analgesics, anti-depressants

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Conditions

The condition(s) this trial relates to.

irritable bowel syndrome

As listed by the trial registrant

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

Irritable bowel syndrome

Contacts and locations

Locations

  • Clinique Universitaire d'Hépato-Gastroentérologie - CHU de Grenoble

    Grenoble, 38043, France

  • Service d'Exploration Fonctionnelle Digestive - Hôpital Edouard Herriot - Hospices Civils de Lyon

    Lyon, 69437, France

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