Irritable Bowel SyndromeStVSIINCT02420158
Trans-cutaneous Vagal Nerve Electrical Stimulation and Irritable Bowel Syndrome
A study testing Trans-cutaneous vagal nerve electrical stimulation in people with Irritable Bowel Syndrome, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
This pilot study plan to investigate the sympathovagal balance in women affected by Irritable Bowel Syndrome (IBS), and to evaluate the effect of 6 months of trans-cutaneous vagal nerve electrical stimulation on digestive physiology (intestinal transit time, intestinal mucosal permeability, systemic and local… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Trans-cutaneous vagal nerve electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesFrance
- Study dates
- May 2015to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women aged 18-60,
- clinical Rome III criteria for IBS
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Clinique Universitaire d'Hépato-Gastroentérologie - CHU de Grenoble
Grenoble, 38043
Service d'Exploration Fonctionnelle Digestive - Hôpital Edouard Herriot - Hospices Civils de Lyon
Lyon, 69437
About this study
Official title: Sympatho-vagal Balance in Patients With Irritable Bowel Syndrome, and Evaluation of a Transcutaneous Vagal Nerve Electrical Stimulation on Symptoms and Quality of Life
This pilot study plan to investigate the sympathovagal balance in women affected by Irritable Bowel Syndrome (IBS), and to evaluate the effect of 6 months of trans-cutaneous vagal nerve electrical stimulation on digestive physiology (intestinal transit time, intestinal mucosal permeability, systemic and local inflammation), symptoms and quality of life.
The safety of the electrical stimulation of the left vagal nerve will also be evaluated.
Ten women, age between 18 and 60, will be included.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Trans-cutaneous vagal nerve electrical stimulation
- Keywords
- Irritable Bowel Syndrome, Vagal nerve stimulation, Quality of life
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-cutaneous vagal nerve electrical stimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| Vagal nerve stimulation | Experimental | Trans-cutaneous vagal nerve electrical stimulation during 6 months Receives: Device: Trans-cutaneous vagal nerve electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of clinical symptoms of IBS, based on the evolution of symptom score (Francis) and symptom scale (UCLA-SSS)
Measured: 3 and 6 months after the beginning of electrical stimulation
Secondary outcomes (4)
Safety and tolerance of trans-cutaneous nerve stimulation as measured by any symptom occurring in relation with electrical stimulation, number of hours per day of system use
Any symptom occurring in relation with electrical stimulation, number of hours per day of system use
Measured: 6 months
Evolution of digestive physiology during vagal nerve stimulation
Digestive physiology is evaluated by intestinal transit time with Smartpill capsule, lactuose/mannitol intestinal permeability test, fecal calprotectin and blood cytokines
Measured: 3 and 6 months
Effect of vagal nerve stimulation on quality of life
Quality of life and psychological questionnaires
Measured: 3 and 6 months
Evaluation of sympatho-vagal balance
Measurement by nocturnal EKG Holter of the variability of the interval RR, as a marker of the sympatho-vagal balance
Measured: 0, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François MION, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02420158
- Sponsor's protocol ID
- 2014.844
- Acronym
- StVSII
- Status last verified
- Jan 2019
- First submitted
- 14 Apr 2015
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Short Communication BIOELECTRONICS IN MEDICINE Volume 3, 2020 - Issue 1 - Pages 5-12 Transcutaneous auricular vagus nerve stimulation for the treatment of irritable bowel syndrome: a pilot, open-label study Francois Mion*,1,2,3 , Sonia Pellissier4, Aur´ elien Garros1, Henri Damon1, Sabine Roman1,2,3 & Bruno Bonaz5,6,7 1Department of Digestive Physiology, Hospices Civils de Lyon, Lyon, France 2Department of Physiology, Universite´ de Lyon, Lyon, France 3Inserm U1032, LabTau, Lyon, France 4Universite´ Savoie Mont Blanc, Universite´ Grenoble Alpes, LIP/PC2S, 73000, Chambe´ ry 5Division of Hepato-Gastroenterology, CHU Grenoble Alpes, 38000 Grenoble, France 6Hepatogastroenterology, Universite´ Grenoble Alpes, Grenoble 7INSERM U1216, Grenoble Institute Neurosciences, Grenoble *Author for correspondence: francois.mion@chu-lyon.fr
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sympatho-vagal Balance in Patients With Irritable Bowel Syndrome, and Evaluation of a Transcutaneous Vagal Nerve Electrical Stimulation on Symptoms and Quality of Life
- ClinicalTrials.gov ID
- NCT02420158
- Acronym / sponsor ID
- StVSII / 2014.844
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, Vagal nerve stimulation, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 17 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study plan to investigate the sympathovagal balance in women affected by Irritable Bowel Syndrome (IBS), and to evaluate the effect of 6 months of trans-cutaneous vagal nerve electrical stimulation on digestive physiology (intestinal transit time, intestinal mucosal permeability, systemic and local inflammation), symptoms and quality of life.
The safety of the electrical stimulation of the left vagal nerve will also be evaluated.
Ten women, age between 18 and 60, will be included.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vagal nerve stimulation | Experimental | Device: Trans-cutaneous vagal nerve electrical stimulationTrans-cutaneous vagal nerve electrical stimulation during 6 months |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- women aged 18-60,
- clinical Rome III criteria for IBS
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trans-cutaneous vagal nerve electrical stimulation | Device | Vagal nerve stimulation |
Primary outcome
Improvement of clinical symptoms of IBS, based on the evolution of symptom score (Francis) and symptom scale (UCLA-SSS)
Time frame: 3 and 6 months after the beginning of electrical stimulation
4 secondary outcomes
Safety and tolerance of trans-cutaneous nerve stimulation as measured by any symptom occurring in relation with electrical stimulation, number of hours per day of system use
Time frame: 6 months
Evolution of digestive physiology during vagal nerve stimulation
Time frame: 3 and 6 months
Effect of vagal nerve stimulation on quality of life
Time frame: 3 and 6 months
Evaluation of sympatho-vagal balance
Time frame: 0, 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Results publicationShort Communication BIOELECTRONICS IN MEDICINE Volume 3, 2020 - Issue 1 - Pages 5-12 Transcutaneous auricular vagus nerve stimulation for the treatment of irritable bowel syndrome: a pilot, open-label study Francois Mion*,1,2,3 , Sonia Pellissier4, Aur´ elien Garros1, Henri Damon1, Sabine Roman1,2,3 & Bruno Bonaz5,6,7 1Department of Digestive Physiology, Hospices Civils de Lyon, Lyon, France 2Department of Physiology, Universite´ de Lyon, Lyon, France 3Inserm U1032, LabTau, Lyon, France 4Universite´ Savoie Mont Blanc, Universite´ Grenoble Alpes, LIP/PC2S, 73000, Chambe´ ry 5Division of Hepato-Gastroenterology, CHU Grenoble Alpes, 38000 Grenoble, France 6Hepatogastroenterology, Universite´ Grenoble Alpes, Grenoble 7INSERM U1216, Grenoble Institute Neurosciences, Grenoble *Author for correspondence: francois.mion@chu-lyon.fr
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François MION, MD principal investigator
Hospices Civils de Lyon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans-cutaneous vagal nerve electrical stimulation in people with Irritable Bowel Syndrome, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of clinical symptoms of IBS, based on the evolution of symptom score (Francis) and symptom scale (UCLA-SSS) (time frame: 3 and 6 months after the beginning of electrical stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02420158, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.