Irritable Bowel Syndrome
Conditions
Keywords
Irritable Bowel Syndrome, Vagal nerve stimulation, 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.
Interventions
DEVICETrans-cutaneous vagal nerve electrical stimulation
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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 | 3 and 6 months | Quality of life and psychological questionnaires |
| Evaluation of sympatho-vagal balance | 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 |
Countries
France
Outcome results
None listed