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

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Trans-cutaneous vagal nerve electrical stimulation
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome, Vagal nerve stimulation, Quality of life

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Clinique Universitaire d'Hépato-Gastroentérologie - CHU de Grenoble
  • Service d'Exploration Fonctionnelle Digestive - Hôpital Edouard Herriot - Hospices Civils de Lyon

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vagal nerve stimulation

Arm Description

Trans-cutaneous vagal nerve electrical stimulation during 6 months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Effect of vagal nerve stimulation on quality of life
Quality of life and psychological questionnaires
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

Full Information

First Posted
April 14, 2015
Last Updated
January 3, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02420158
Brief Title
Trans-cutaneous Vagal Nerve Electrical Stimulation and Irritable Bowel Syndrome
Acronym
StVSII
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Irritable Bowel Syndrome, Vagal nerve stimulation, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vagal nerve stimulation
Arm Type
Experimental
Arm Description
Trans-cutaneous vagal nerve electrical stimulation during 6 months
Intervention Type
Device
Intervention Name(s)
Trans-cutaneous vagal nerve electrical stimulation
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Description
Any symptom occurring in relation with electrical stimulation, number of hours per day of system use
Time Frame
6 months
Title
Evolution of digestive physiology during vagal nerve stimulation
Description
Digestive physiology is evaluated by intestinal transit time with Smartpill capsule, lactuose/mannitol intestinal permeability test, fecal calprotectin and blood cytokines
Time Frame
3 and 6 months
Title
Effect of vagal nerve stimulation on quality of life
Description
Quality of life and psychological questionnaires
Time Frame
3 and 6 months
Title
Evaluation of sympatho-vagal balance
Description
Measurement by nocturnal EKG Holter of the variability of the interval RR, as a marker of the sympatho-vagal balance
Time Frame
0, 3 and 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François MION, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Universitaire d'Hépato-Gastroentérologie - CHU de Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Service d'Exploration Fonctionnelle Digestive - Hôpital Edouard Herriot - Hospices Civils de Lyon
City
LYON Cedex 03
ZIP/Postal Code
69437
Country
France

12. IPD Sharing Statement

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Trans-cutaneous Vagal Nerve Electrical Stimulation and Irritable Bowel Syndrome

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