Trans-cutaneous Vagal Nerve Electrical Stimulation and Irritable Bowel Syndrome (StVSII)
September 8, 2025 updated by: Hospices Civils de Lyon
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Grenoble, France, 38043
- Clinique Universitaire d'Hépato-Gastroentérologie - CHU de Grenoble
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Lyon, France, 69437
- Service d'Exploration Fonctionnelle Digestive - Hôpital Edouard Herriot - Hospices Civils de Lyon
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 56 years (Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Vagal nerve stimulation
Trans-cutaneous vagal nerve electrical stimulation during 6 months
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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
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3 and 6 months after the beginning of electrical stimulation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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Any symptom occurring in relation with electrical stimulation, number of hours per day of system use
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6 months
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Evolution of digestive physiology during vagal nerve stimulation
Time Frame: 3 and 6 months
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Digestive physiology is evaluated by intestinal transit time with Smartpill capsule, lactuose/mannitol intestinal permeability test, fecal calprotectin and blood cytokines
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3 and 6 months
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Effect of vagal nerve stimulation on quality of life
Time Frame: 3 and 6 months
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Quality of life and psychological questionnaires
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3 and 6 months
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Evaluation of sympatho-vagal balance
Time Frame: 0, 3 and 6 months
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Measurement by nocturnal EKG Holter of the variability of the interval RR, as a marker of the sympatho-vagal balance
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0, 3 and 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: François MION, MD, Hospices Civils de Lyon
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2015
Primary Completion (Actual)
August 1, 2018
Study Completion (Actual)
August 1, 2018
Study Registration Dates
First Submitted
April 14, 2015
First Submitted That Met QC Criteria
April 16, 2015
First Posted (Estimated)
April 17, 2015
Study Record Updates
Last Update Posted (Estimated)
September 9, 2025
Last Update Submitted That Met QC Criteria
September 8, 2025
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014.844
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