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Completed

NCT Number: NCT02420158

Trans-cutaneous Vagal Nerve Electrical Stimulation and Irritable Bowel Syndrome

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Universitaire d'Hépato-Gastroentérologie - CHU de Grenoble, Grenoble, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trans-cutaneous vagal nerve electrical stimulation

Device

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    Any symptom occurring in relation with electrical stimulation, number of hours per day of system use

  2. Evolution of digestive physiology during vagal nerve stimulation

    Time frame: 3 and 6 months

    Digestive physiology is evaluated by intestinal transit time with Smartpill capsule, lactuose/mannitol intestinal permeability test, fecal calprotectin and blood cytokines

  3. Effect of vagal nerve stimulation on quality of life

    Time frame: 3 and 6 months

    Quality of life and psychological questionnaires

  4. Evaluation of sympatho-vagal balance

    Time frame: 0, 3 and 6 months

    Measurement by nocturnal EKG Holter of the variability of the interval RR, as a marker of the sympatho-vagal balance

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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

Acronym: StVSII

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 17, 2015
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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