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This project involves the development, validation and application of a novel test using MRI to assess gastrointestinal motility a vital process that mixes the contents of our digestive tract. This process frequently becomes deranged in conditions like chronic constipation, Parkinson's and Crohn's disease.
Gastrointestinal motility refers to the contractile actions in the gut that serve to mix our food and propel it through out digestive tract. Although known to be involved in a range of conditions like chronic constipation, Parkinson's and Crohn's disease, investigator have never had effective tests with which to study the process. Advances in medical imaging technologies now make it possible to both see and quantify this process non-invasively using MRI. In this study the investigator first of all validate that our MRI based analysis is robust and valid, producing predictable results against range of known stimuli. The investigator then apply the technique to a cohort of participants with Chronic Intestinal Pseudo-Obstruction. These participants are known to have hypo-motile small bowels and demonstration with our MRI technique would serve as further validation. The investigator also investigate two cohorts of people with and without gastrointestinal diseases to better understand how the technique may work in the clinical setting.
By the end of this project The investigator will have generated robust initial evidence to validate our MRI technique and clinical data to inform use further research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Subject-Drug Study | The first part of this investigation is an interventional blinded cross over study with two dosing dates spread at least one week apart. Each volunteer will receive baseline scans before drug/placebo which will be used to assess intra---patient variation over the two study dates after which the drug or saline placebo will be administered with each volunteer acting as their own control to assess software ability to quantify changes in bowel motility. | ||
| Dysmotility Subjects-Drug Study | The second component of this study will be exactly the same for the participants with dysmotility except the time to repeat scan will be reduced with a follow up time aimed at around 1---3 days reducing patient time off medication | ||
| Reference Range Study | The third component of this study will assess basal small bowel motility in larger numbers of healthy controls, dysmotility subjects and irritable bowel syndrome to establish reference ranges to inform future clinical investigations and guide clinical decision making using global motility scoring. Each scan will last around 20 minutes and will not involve follow up or use of pharmaceutical agents. | ||
| Desmotility Reversibility Study | The fourth component of the study will assess small bowel motility in a cohort of Crohns disease patients will small bowel disease before and 11---16 weeks after starting anti TNF alpha therapy, or undergoing endoscopic dilatation of a small bowel stricture. Each scan will last around 45 minutes |
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| Measure | Description | Time Frame |
|---|---|---|
| To establish the reproducibility of software quantified small bowel motility in normal individuals using processed MRI derived dynamic small bowel sequences. | 7 years | |
| To assess the ability of the software to detect changes in small bowel motility after provocation with a known pro or anti-kinetic agent in normal individuals | 7 years | |
| To evaluate the variation in software quantified small bowel motility according to the positioning of the image slice in the abdomen during data acquisition. | 7 years | |
| To compare dysmotility patients motility to that of normal controls with and in the absence of pro---kinetic agent. | 7 years | |
| To establish basal bowel motility reference ranges in a larger cohort of control, dysmotility and irritable bowel syndrome subjects. | 7 years | |
| To assess the reversibility of dysmotility after treatment of the primary underlying condition, if known | 7 years |
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Inclusion Criteria:
ELIGIBILITY CRITERIA - CONTROL SUBJECTS DRUG STUDY:
ELIGIBILITY CRITERIA - DYSMOTILITY SUBJECTS DRUG STUDY:
ELIGIBILITY CRITERIA - REFERENCE RANGE STUDY (NORMAL PARTICIPANTS):
• Adult (>16 years)
ELIGIBILITY CRITERIA - REFERENCE RANGE STUDY (DYSMOTILITY/IBS):
ELIGIBILITY CRITERIA - DYSMOTILITY REVERSIBILITY STUDY:
Exclusion Criteria:
EXCLUSION CRITERIA - CONTROL SUBJECTS DRUG STUDY:
EXCLUSION CRITERIA - REFERENCE RANGE STUDY (NORMAL PARTICIPANTS):
EXCLUSION CRITERIA - REFERENCE RANGE STUDY (DYSMOTILITY/IBS):
EXCLUSION CRITERIA - DYSMOTILITY REVERSIBILITY STUDY:
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Volunteers on the placebo---controlled drug study using neostigmine will be recruited from UCL staff and student population by internal advertisement. Patients with CIPO and (13) Version 4.1 dysmotility will be identified from patient records held in the gastroenterology departments at UCL and Queen Mary's University London.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alex Menys | Contact | 79324 | alex.meny.09@ucl.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Stuart Taylor | Centre for Medical Imaging | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Medical Imaging | Recruiting | London | London | NW1 2PG | United Kingdom |
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