Exercise and Vagus Nerve Stimulation in IBS

NACompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

June 1, 2024

Primary Completion Date

November 1, 2024

Study Completion Date

January 1, 2025

Conditions
Irritable Bowel Syndrome (IBS)
Interventions
DEVICE

Auricular Vagus Nerve Stimulation (aVNS)

"This intervention involves transcutaneous auricular vagus nerve stimulation (taVNS) using the VagusStim device. The device consists of earphones tailored to fit the individual's ear size (S, M, L) and is connected to a TENS unit. The stimulation is applied to the tragus and concha of the ear for 30 minutes, three times a week, over a 4-week period. The device operates with a pulse duration of less than 500 microseconds, a frequency of 10 Hz, and in a modulated TENS mode. The current intensity is individually adjusted to the participant's sensory threshold. This method targets the vagus nerve to potentially regulate autonomic activity and improve symptoms of Irritable Bowel Syndrome (IBS).~The study combines this intervention with a low FODMAP diet for all participants, distinguishing it from studies focused solely on vagus nerve stimulation or dietary changes."

BEHAVIORAL

Aerobic Exercise Therapy

"This intervention involves a structured aerobic exercise program designed to improve physical activity levels and modulate symptoms of Irritable Bowel Syndrome (IBS). Participants engage in walking exercises at a moderate intensity, maintaining 50-70% of their maximum heart rate, ensuring the ability to converse comfortably during the activity. The exercise sessions last for at least 30 minutes, three days a week, on alternate days, over a 4-week period.~Participants are individually trained and monitored to ensure proper technique and adherence to the exercise protocol. The intervention is combined with a low FODMAP diet, providing a multimodal approach to IBS symptom management. This distinguishes it from other interventions by emphasizing physical activity's role in enhancing gastrointestinal and overall health."

BEHAVIORAL

Low FODMAP Diet Intervention

"This intervention involves the implementation of a low FODMAP (fermentable oligo-, di-, mono-saccharides, and polyols) diet to manage symptoms of Irritable Bowel Syndrome (IBS). Participants receive individualized training on the diet before the study begins. The diet eliminates high FODMAP foods known to exacerbate IBS symptoms, such as certain fruits, vegetables, dairy products, and sweeteners, for a duration of 4 weeks.~Participants follow the prescribed dietary protocol under guidance, ensuring adherence and addressing specific nutritional needs. This intervention aims to reduce gastrointestinal distress by limiting fermentable carbohydrates, distinguishing it from other IBS management strategies that do not focus on dietary modifications."

Trial Locations (1)

PR2 3AQ

Astoria Care, Preston

All Listed Sponsors
lead

Bahçeşehir University

OTHER

NCT06769516 - Exercise and Vagus Nerve Stimulation in IBS | Biotech Hunter | Biotech Hunter