Status:
COMPLETED
Vagal Nerve Stimulation for Intestinal Barrier Dysfunction in Healthy Volunteers
Lead Sponsor:
Queen Mary University of London
Conditions:
Intestinal Barrier Dysfunction
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 heal...
Detailed Description
Stress - a state which evokes a 'fight or flight' or sympathetic response from the human organism - has been implicated in the propagation of inflammation in patients with inflammatory bowel disease (...
Eligibility Criteria
Inclusion
- Healthy males and females between the ages of 18 - 65
- Participants who are able to give informed consent
- Volunteers should be able to attend the Wingate institute on 2 occasions
Exclusion
- Inclusion criteria:
- Healthy males and females between the ages of 18 - 65
- Participants who are able to give informed consent
- Volunteers should be able to attend the Wingate institute on 2 occasions
- Exclusion Criteria
- Inclusion criteria not met
- Past medical history of diabetes (type 1 or 2)
- Past medical history of inflammatory bowel disease, Coeliac disease, a diagnosis of irritable bowel syndrome or significant gastrointestinal symptoms not otherwise medically diagnosed
- Patients actively taking non-steroidal anti-inflammatory medications (NSAIDs) or corticosteroids
- Probiotic or antibiotic intake over the past 3 months
- Pregnant or breast feeding participants
- Participants with known or suspected disorders of the hypothalamo-pituatory axis
- Participants with a history of anaphylaxis
- Chronic disease or any regular medication intake not already specified above; in particular:
- Participants with known or suspected severe cardiac disease (e.g., symptomatic coronary artery disease, prior myocardial infarction, congestive heart failure (CHF);
- Participants with clinically significant abnormal screening 3 lead Electrocardiogram (ECG) e.g. second and third degree heart block, prolonged QT interval, atrial fibrillation, atrial flutter, history of ventricular tachycardia or ventricular fibrillation, or clinically significant premature ventricular contraction);
- Participants who are implanted with an electrical and/or neurostimulator device (e.g. cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, cochlear implant, sphenopalatine ganglion stimulator or occipital nerve stimulator).
Key Trial Info
Start Date :
May 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2019
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04061564
Start Date
May 13 2019
End Date
September 15 2019
Last Update
March 8 2022
Active Locations (1)
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1
The Wigate Institute, Barts and the London School of Medicine and Dentistry
London, United Kingdom, N1 1HQ