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NCT02420158 Clinical Trial

Trans-cutaneous Vagal Nerve Electrical Stimulation and Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02420158
Other study ID # 2014.844
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2015
Est. completion date August 2018

Study information
Verified date January 2019
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date August 2018
Est. primary completion date August 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Trans-cutaneous vagal nerve electrical stimulation

Locations
Country Name City State
France Clinique Universitaire d'Hépato-Gastroentérologie - CHU de Grenoble Grenoble
France Service d'Exploration Fonctionnelle Digestive - Hôpital Edouard Herriot - Hospices Civils de Lyon LYON Cedex 03

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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 6 months
Secondary 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 3 and 6 months
Secondary Effect of vagal nerve stimulation on quality of life Quality of life and psychological questionnaires 3 and 6 months
Secondary 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 0, 3 and 6 months
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