Irritable Bowel Syndrome (IBS) Clinical Trials

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Transauricular Neurostimulation for Irritable Bowel Syndrome

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This single-site, open-label pilot study will evaluate transcutaneous auricular neurostimulation using the Sparrow Link device as a treatment for adolescents aged 12 to 18 years with abdominal pain related to disorders of gut-brain interaction. Up to 30 participants will be enrolled, with a goal of 20 completing the study. Participants will use the device for at least one hour daily for 4 weeks and complete questionnaires through week 8. The study will assess adherence, retention, safety, and preliminary changes in abdominal pain, bowel symptoms, quality of life, and anxiety.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 18
Healthy Volunteers: f
View:

• Age 12-18 years.

• Clinical diagnosis of an abdominal pain-related disorder of gut-brain interaction (DGBI) meeting Rome IV criteria.

• Average abdominal pain intensity ≥3 on a 0-10 scale and pain on at least 2 days per week.

• Proper fit of the Sparrow earpiece on the left ear, as determined by study personnel.

Locations
United States
Ohio
Nationwide Children's Hospital
RECRUITING
Columbus
Contact Information
Primary
Peter Lu, MD
Peter.Lu@nationwidechildrens.org
(614) 722-3421
Backup
Eduardo Castillo Leon, MD
eduardo.castilloleon@nationwidechildrens.org
617-722-3874
Time Frame
Start Date: 2025-10-23
Estimated Completion Date: 2026-10-30
Participants
Target number of participants: 30
Treatments
Experimental: Transauricular neurostimulation
All participants receive active transcutaneous auricular neurostimulation using the Sparrow Link device for at least one hour daily for 4 weeks, with follow-up assessments through week 8.
Related Therapeutic Areas
Sponsors
Leads: Nationwide Children's Hospital

This content was sourced from clinicaltrials.gov