Magnetic Resonance Imaging Assessment of Small Bowel Motility

NCT02754869 | Unknown DMC

• 1 other identifier: 11/0307
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Motility Disorder of Intestine

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (4)

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

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• ELIGIBILITY CRITERIA - CONTROL SUBJECTS DRUG STUDY:
• Adult (\>16 years)
• Body Mass Index within the range of (18---25)
• ELIGIBILITY CRITERIA - DYSMOTILITY SUBJECTS DRUG STUDY:
• Adult patients (\>16 years) 2
• Dysmotility diagnosis including CIPO
• Body Mass Index within the range of (18---35)
• ELIGIBILITY CRITERIA - REFERENCE RANGE STUDY (NORMAL PARTICIPANTS):
• Adult (\>16 years)
• ELIGIBILITY CRITERIA - REFERENCE RANGE STUDY (DYSMOTILITY/IBS):
• Adult patients (\>16 years)
• Dysmotility, CIPO or IBS diagnosis
• ELIGIBILITY CRITERIA - DYSMOTILITY REVERSIBILITY STUDY:
• Adult (\>16 years)
• Known small bowel Crohn's disease starting anti TNF alpha medication or undergoing endoscopic small bowel stricture dilatation.

You may not qualify if:

• Any contraindications to MRI scans (e.g. Implanted cardiac pacemaker, defibrillator device)
• Inability to give consent
• Treatment for any chronic illness
• Use of laxatives, anti---diarrhoeals or any drugs affecting GI motility (including NSAIDs) prohibited within one week of the scan.
• Cardiac symptoms (palpitations).
• Abnormal GI symptoms (eg. constipation, diarrhea, bloating, pain) as per the Rome III criteria for Irritable Bowel Syndrome
• Pregnancy
• Any contraindications to MRI scans (e.g. Implanted cardiac pacemaker, defibrillator device)
• Inability to give consent
• Use of laxatives, anti---diarrhoeals or any drugs affecting GI motility (including NSAIDs) prohibited within 1---3 days (or according to half life of drug) of the scan.
• Cardiac symptoms (palpitations).
• Pregnancy
• Asthma
• Any contraindications to MRI scans (e.g. Implanted cardiac pacemaker, defibrillator device)
• Inability to give consent 3. Treatment for any chronic illness

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

Centre for Medical Imaging

London, London, NW1 2PG, United Kingdom

RECRUITING

Study Officials

• Stuart Taylor

  Centre for Medical Imaging

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex Menys

CONTACT

alex.meny.09@ucl.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: April 28, 2016
• Study Start: February 1, 2011
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: April 28, 2016

Record last verified: 2015-11

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)