Clinical Trial: Trans-cutaneous Vagal Nerve Electrical Stimulation and Irritable Bowel Syndrome
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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
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.
Detailed Summary:
Sponsor: Hospices Civils de Lyon
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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
- 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
- Effect of vagal nerve stimulation on quality of life [ Time Frame: 3 and 6 months ]Quality of life and psychological questionnaires
- 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
Original Secondary Outcome: Same as current
Information By: Hospices Civils de Lyon
Dates:
Date Received: April 14, 2015
Date Started: May 2015
Date Completion: December 2017
Last Updated: August 5, 2016
Last Verified: August 2016