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New treatment option for Irritable Bowel Syndrome
Official title Vagal Nerve Stimulation in Irritable Bowel Syndrome
ClinicalTrials.gov ID: NCT06090110
What this study is testing
- What it's testing
- This randomized control trial aims to evaluate the effect of transcutaneous auricular vagal nerve stimulation in patients with irritable bowel syndrome. The intervention will be 8 weeks of treatment with a vagal nerve stimulator.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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).
You likely can't join if
- A history of abdominal surgery, except for uncomplicated appendectomy, laparoscopic cholecystectomy and hysterectomy is present or otherwise based on...
- Presence of metallic prostheses, pacemakers, metal clips on blood vessels, metal parts in the eye, an intrauterine device (with the exception of the...
- 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...
See the full eligibility 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.
- 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...
- If the subject has a cardiac arrhythmia, the attending physician will be consulted before participation.
The study team makes the final eligibility decision.
Where it's taking place
- Maastricht, Limburg, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Maastricht, Limburg, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.