CompletedNot Applicable

Effect of taVNS on Abdominal Pain and Other Symptoms in Constipation-predominant Irritable Bowel Syndrome

China42 participantsStarted 2020-03-01

Plain-language summary

This study aims to investigate the effects and possible mechanisms of transcutaneous auricular vagal nerve stimulation (taVNS) on abdominal pain and other symptoms in patients with IBS-C.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. willing to sign a written informed consent form
. met the Rome IV diagnostic criteria for IBS-C

Exclusion criteria

. history of previous abdominal surgery (other than appendectomy)
. presence of carcinoma
. any organic diseases causing constipation or neurologic diseases such as multiple sclerosis, rachischisis, Parkinson's disease, or spinal cord injury
. taking antidepressant agents including tricyclic antidepressants and selective serotonin reuptake inhibitors
. serious concomitant disease of the heart, liver, kidney, or diabetes
. pregnancy or lactation
. participating in another trial or enrolled in a trial during the past month
. allergic reaction to surface electrodes

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in аbdominal pain between sham and active taVNS

Timeframe: 4 weeks

Trial details

NCT IDNCT05392439

SponsorTongji University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-15

View on ClinicalTrials.gov More Constipation-predominant Irritable Bowel Syndrome trials