Summary

Eligibility
for people ages 18-50 (full criteria)
Location
at UCLA
Dates
study started
study ends around
Principal Investigator
by Lin Chang, MD (ucla)

Description

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.

Official Title

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

Keywords

Irritable Bowel Syndrome (IBS), Irritable Bowel Syndrome, Digestive System Diseases, Vagus Nerve Stimulation, Heart Rate Variability, Brain-Gut Axis, Truvaga Plus, nVNS

Eligibility

You can join if…

Open to people ages 18-50

  • Age 18-50 years.
  • Meets Rome V diagnostic criteria for IBS-D or IBS-M.
  • At least moderate IBS symptom severity, defined as IBS-SSS ≥175.
  • For females: premenopausal with generally regular menstrual cycles and willing to complete study visits within the study-specified menstrual-cycle window when feasible.
  • Able to understand and provide informed consent in English.
  • Willing and able to complete questionnaires, biospecimen collection, wearable monitoring, MRI procedures, and randomized study requirements.

You CAN'T join if...

  • Individuals with obesity (BMI > 30).
  • Evidence or history of another gastrointestinal disease that could explain symptoms, including inflammatory bowel disease or celiac disease, unless adequately excluded by clinical evaluation or prior testing.
  • Pregnancy or a positive pregnancy test.
  • Perimenopausal or postmenopausal status.
  • Previous use in the last 3 months OR current use of hormonal medications, including hormonal contraceptives (i.e. birth control pills, patches, implants, or intrauterine devices (IUDs)) or hormone replacement therapy
  • MRI contraindication, including a non-removable ferromagnetic implant or device, prior significant tattoo-related heating or burns, severe claustrophobia that cannot be managed, or another condition judged unsafe for MRI.
  • Major active psychiatric illness (e.g., schizophrenia, bipolar disorder), significant neurologic or central nervous system disease, or another medical condition that could affect safety, adherence, or interpretation of study outcomes.
  • Current participation in another IBS-specific intervention study or planned initiation of a new IBS-directed treatment during the 8-week randomized period.
  • Contraindication to cervical nVNS or inability to use the device safely.
  • Dermatologic conditions affecting the neck region that would interfere with nVNS placement
  • Any implanted electrical device
  • Any metallic device implanted at or near the neck
  • History of cervical vagotomy
  • Use of another electrical device at the same time (e.g., TENS unit, muscle stimulator) or any portable electronic device
  • Movement disorder
  • Clinically significant hypertension, hypotension, bradycardia, or tachycardia.
  • Cardiac disease or atherosclerotic cardiac disease, including congestive heart failure, known severe coronary artery disease, or recent myocardial infarction within 5 years.
  • Past abdominal surgery (except for appendectomy, cholecystectomy, benign polypectomy, hiatus hernia)
  • Inability or unwillingness to provide informed consent or complete study procedures in English.

Location

  • University of California Los Angeles
    Los Angeles California 90024 United States

Lead Scientist at University of California Health

  • Lin Chang, MD (ucla)
    Professor, Medicine. Authored (or co-authored) 53 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT07926945
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated