MedTrace Logo

Vagal Nerve Stimulation for Intestinal Barrier Dysfunction in Healthy Volunteers

NCT04061564 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-03-08

No results posted yet for this study

Summary

This is a proof of concept randomised placebo controlled crossover trial to evaluate the effect of transcutaneous vagal nerve stimulation on a stress model of increased intestinal permeability in healthy human subjects.

Intestinal permeability perturbation is a phenomenon which is being increasingly recognised as a contributing factor to a multitude of diseases - including inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS). There are currently limited effective treatment methods known to improve this intestinal permeability perturbation and the use of vagal nerve stimulation would present itself as an inexpensive, non-invasive and non-pharmacological method of reversing this dysfunction. Vagal nerve stimulation efficacy in reversing stress related intestinal barrier dysfunction is available from proof of concept animal models.

This mechanistic project is an important first step in this field of research and will serve as a basis for further research into the role of vagal nerve stimulation in intestinal barrier dysfunction.

Conditions

  • Intestinal Barrier Dysfunction

Interventions

DEVICE

Vagal nerve stimulation

The participant will be administered electrical stimulation at a level specifically set to their comfort. This will be performed using a TENS machine device.

Sponsors & Collaborators

  • Queen Mary University of London

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-13
Primary Completion
2019-08-15
Completion
2019-09-15

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04061564 on ClinicalTrials.gov