Vagal Nerve Stimulation in Irritable Bowel Syndrome (RESILIENCE)
Irritable Bowel Syndrome
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring vagal nerve stimulation
Eligibility Criteria
Inclusion Criteria: A diagnosis of IBS according to Rome IV criteria (3), as follows: Recurrent abdominal pain, on average, at least 1 day per week in the last 3 months, associated with 2 or more of the following criteria: Related to defecation. Associated with a change in stool frequency. Associated with a change in stool from (appearance). Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis. Age between 18 and 75 years; Ability to understand and speak the Dutch language. Ability to understand how to utilize the ESM application. Exclusion Criteria: A history of abdominal surgery, except for uncomplicated appendectomy, laparoscopic cholecystectomy and hysterectomy is present or otherwise based on the principal investigator's judgement. Presence of metallic prostheses, pacemakers, metal clips on blood vessels, metal parts in the eye, an intrauterine device (with the exception of the Mirena IUD), metal braces, facial tattoos and/or metal objects. History of major head trauma or head/brain surgery History of claustrophobia Pregnancy, lactation, intention to become pregnant during the study period Students and employees of Maastricht University are not precluded from participation, unless they have a direct personal, professional or hierarchical position with regards to any of the study team members or their department. If the subject has a cardiac arrhythmia, the attending physician will be consulted before participation.
Sites / Locations
- Maastricht University
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Intervention
placebo
transcutaneous auricular vagal nerve stimulation, for 8 weeks at least one hour a day
sham stimulation with a non-conducting electrode, for 8 weeks at least one hour a day