The study of Brain-Gut Permeability by means of MRI: version 1.2
Research type
Research Study
Full title
An MRI-based investigation to study the gut and choroid brain plexus vascular barrier
IRAS ID
299904
Contact name
Jennifer Boston
Contact email
Sponsor organisation
University of Nottingham
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
Research Summary:
It has been suggested that changes in the gut affect the brain and how we behave, impacting mood and anxiety. The gut and the brain are connected through different pathways in the body. Our gut collects messages and sends them to the brain and the brain collects messages and sends them to the gut. The purpose of this study is to use novel Magnetic Resonance Imaging (MRI) measures to monitor changes in the gut and brain ‘permeability’. This involves using MRI to measure how easily substances pass through the gut wall into the blood, and then how they pass from the blood into the fluid surrounding the brain. This is a single centre study, and we are planning to scan 15 patients with Crohn’s disease. This work will help us to develop a non-invasive test that can be used in a wider group of people, to tell us more about how different disorders can affect how the gut and brain interact with each other. Our goal is to better understand this relationship in order to help develop suitable treatments for patients.
Summary of Results:
Aims and Objectives: This study aimed to determine the feasibility of a single Magnetic Resonance Imaging (MRI) study to concurrently evaluate the permeability of the gut and brain permeability in humans. The possibility of developing a non-invasive test to study the pathophysiological mechanisms of gut diseases/disorders would provide an imaging technique to use to study developing treatments likely to influence the brain response modulating the gut disease/disorder.
Main findings: This study developed a contrast free non-invasive MRI acquisition and analysis methods to study brain permeability, which could be compared to contrast based brain MRI scans to measure gut and brain.
Subjects attended three study visits. Visit 1 was a screening visit to which Interested participants were invited and was combined with Visit 2. Patients underwent a screening procedure including MRI safety, quality of life, anxiety and depression scores, and inflammatory bowel disease (IBD)-Fatigue score. Only patients that were on stable IBD disease medication for 6 months prior to the scan session, had no use of steroids for 3 months prior, and had no immediate plan for surgery, were included. Patients were fasted for 6 hours prior to the scan. Experimental procedures for all studies were approved by the University of Nottingham Medical School’s Ethics Committee (Ethics REC ref: 21/PR/0837).
51 participants were approached, with 10 (5 females, age: 44+/-13 (mean +/- SEM)) participants then eligible to take part in Visit 2 and 3 which each comprised an MRI scan session. All subjects gave written informed consent. One patient drop out the study as she could not tolerate to lay in the scanner because of her back pain during visit 3.
Participants attended the Sir Peter Mansfield Imaging Centre, participating in two scan MRI sessions on separate days. Visit 2 was a brain only scan session whilst Visit 3 comprised combined brain-gut imaging.
Objectives achieved and plan for publication and dissemination: The study confirmed its objectives. Patients were all IBD with terminal ileum disease with range of different inflammatory activity and without major comorbidities. In these 7 out of 9 patients it was possible to assess gut permeability. For 2 subjects the automated analysis failed to find any regions of interest in the gut wall.
Currently, the brain data is undergoing to final stages of analysis to compare the non-contrast and contrast MRI scans. Data obtained from both brain and gut analysis will be combined with clinical data and questionnaires scores to assess potential correlation between brain and/or gut permeability and quality of life, fatigue and/or psychological factors.
We expect completion of this final stage of the brain analysis in the next 3 months. Having completed this final stage the study will be submitted for publication in a Gastroenterology journal, with a newsletter to feedback to partiREC name
London - Westminster Research Ethics Committee
REC reference
21/PR/0837
Date of REC Opinion
12 Jul 2021
REC opinion
Favourable Opinion