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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Clinique Universitaire d'Hépato-Gastroentérologie - CHU de Grenoble
Grenoble, France
Service d'Exploration Fonctionnelle Digestive - Hôpital Edouard Herriot - Hospices Civils de Lyon
Lyon, France
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
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
Time frame: 6 months
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
Time frame: 3 and 6 months
Effect of vagal nerve stimulation on quality of life
Quality of life and psychological questionnaires
Time frame: 3 and 6 months
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
Time frame: 0, 3 and 6 months
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