Trans-cutaneous Vagal Nerve Electrical Stimulation and Irritable Bowel Syndrome (StVSII)

January 3, 2019 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

  • France
      • Grenoble, France, 38043
        • Clinique Universitaire d'Hépato-Gastroentérologie - CHU de Grenoble
      • LYON Cedex 03, France, 69437
        • Service d'Exploration Fonctionnelle Digestive - Hôpital Edouard Herriot - Hospices Civils de Lyon

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

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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
Experimental: Vagal nerve stimulation
Trans-cutaneous vagal nerve electrical stimulation during 6 months
Device: Trans-cutaneous vagal nerve electrical stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 and 6 months after the beginning of electrical stimulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
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 and 6 months
Effect of vagal nerve stimulation on quality of life
Time Frame: 3 and 6 months
Quality of life and psychological questionnaires
3 and 6 months
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
0, 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: François MION, MD, Hospices Civils de Lyon

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 (Estimate)

April 17, 2015

Study Record Updates

Last Update Posted (Actual)

January 4, 2019

Last Update Submitted That Met QC Criteria

January 3, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014.844

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Irritable Bowel Syndrome

Clinical Trials on Trans-cutaneous vagal nerve electrical stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe