Effects of Non-invasive Vagal Nerve Stimulation on Clinical, Peripheral Biologic, and Brain Measures of Stress Reactivity in Irritable Bowel Syndrome: a Randomized Controlled Trial

Summary

Irritable bowel syndrome (IBS) is a chronic disorder of gut-brain interaction that causes abdominal pain and altered bowel habits. Many people with IBS also experience symptoms outside the bowel, such as headaches, widespread pain, poor sleep, anxiety, and depression; these symptoms are especially common in females. This study focuses on stress reactivity (SR), a persistent pattern of stress-system activity that may be linked to autonomic nervous system function, immune activity, the gut microbiome, and brain processing. The investigators will enroll adults with at least moderate IBS symptoms and randomly assign them to 8 weeks of non-invasive vagal nerve stimulation (nVNS) or Usual Care. Participants assigned to nVNS will use a handheld device on the left side of the neck at home twice daily. The investigators will compare changes in IBS severity and other physical symptoms and examine whether baseline or treatment-related changes in blood, stool, heart-rate variability, sex hormones, and brain imaging measures are associated with response. The study will also explore whether treatment effects and predictors differ by sex.

Eligibility

Age range

18–50 years

Sex

All

Healthy volunteers

No