NCT02420158

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2015

Completed
14 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

September 9, 2025

Status Verified

January 1, 2019

Enrollment Period

3.3 years

First QC Date

April 14, 2015

Last Update Submit

September 8, 2025

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel SyndromeVagal nerve stimulationQuality of life

Outcome Measures

Primary Outcomes (1)

  • Improvement of clinical symptoms of IBS, based on the evolution of symptom score (Francis) and symptom scale (UCLA-SSS)

    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

    6 months

  • Evolution of digestive physiology during vagal nerve stimulation

    3 and 6 months

  • Effect of vagal nerve stimulation on quality of life

    3 and 6 months

  • Evaluation of sympatho-vagal balance

    0, 3 and 6 months

Study Arms (1)

Vagal nerve stimulation

EXPERIMENTAL

Trans-cutaneous vagal nerve electrical stimulation during 6 months

Device: Trans-cutaneous vagal nerve electrical stimulation

Interventions

Trans-cutaneous vagal nerve electrical stimulationDEVICE
Vagal nerve stimulation

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women aged 18-60,
  • clinical Rome III criteria for IBS

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinique Universitaire d'Hépato-Gastroentérologie - CHU de Grenoble

Grenoble, 38043, France

Location

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

Lyon, 69437, France

Location

Related Publications (1)

  • 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

    RESULT

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • François MION, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2015

First Posted

April 17, 2015

Study Start

May 1, 2015

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

September 9, 2025

Record last verified: 2019-01

Locations

FR(2)