An interventional study of Trans-cutaneous vagal nerve electrical stimulation in Irritable Bowel Syndrome, sponsored by Hospices Civils de Lyon. Completed at 2 sites in France. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-09-09.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Treatment
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.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's enrollment of 18 is below the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Trans-cutaneous vagal nerve electrical stimulation during 6 months
Device: Trans-cutaneous vagal nerve electrical stimulation
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
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon