Motility Disorder of IntestineNCT02754869
Magnetic Resonance Imaging Assessment of Small Bowel Motility
An observational study of Motility Disorder of Intestine, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Motility Disorder of Intestine
- How many people
- 172 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2011to Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Show all 15Show fewer
- 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.
Who cannot join
- 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
Show all 25Show fewer
- Pregnancy
- Asthma EXCLUSION CRITERIA - DYSMOTILITY SUBJECTS DRUG STUDY: (18) Version 4.1
- 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
- EXCLUSION CRITERIA - REFERENCE RANGE STUDY (NORMAL PARTICIPANTS):
- Any contraindications to MRI scans (e.g. Implanted cardiac pacemaker, defibrillator device)
- Inability to give consent 3. Treatment for any chronic illness
- 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.
- EXCLUSION CRITERIA - REFERENCE RANGE STUDY (DYSMOTILITY/IBS):
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
Alex Menys contact
United Kingdom1 site, 1 recruiting
- Recruiting
Centre for Medical Imaging
London, London, NW1 2PG
Alex Menys, alex.menys.09@ucl.ac.uk
About this study
Official title: Post-Hoc Analysis of Dynamic Magnetic Resonance Sequences to Establish Descriptive Metrics for Small Bowel Motility in Vivo
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.
Read the detailed description
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.
- Conditions
- Motility Disorder of Intestine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the reproducibility of software quantified small bowel motility in normal individuals using processed MRI derived dynamic small bowel sequences.
Measured: 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
Measured: 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.
Measured: 7 years
To compare dysmotility patients motility to that of normal controls with and in the absence of pro---kinetic agent.
Measured: 7 years
To establish basal bowel motility reference ranges in a larger cohort of control, dysmotility and irritable bowel syndrome subjects.
Measured: 7 years
To assess the reversibility of dysmotility after treatment of the primary underlying condition, if known
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startFeb 2011
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motility Disorder of IntestineStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stuart Taylor, Principal investigator, Centre for Medical Imaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754869
- Sponsor's protocol ID
- 11/0307
- Status last verified
- Nov 2015
- First submitted
- 23 Feb 2016
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Hoc Analysis of Dynamic Magnetic Resonance Sequences to Establish Descriptive Metrics for Small Bowel Motility in Vivo
- ClinicalTrials.gov ID
- NCT02754869
- Acronym / sponsor ID
- 11/0307
- Conditions
- Motility Disorder of Intestine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- Adult (>16 years)
- Body Mass Index within the range of (18---25)
- Adult patients (>16 years) 2
- Dysmotility diagnosis including CIPO
- Body Mass Index within the range of (18---35)
Key exclusion criteria (25 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To establish the reproducibility of software quantified small bowel motility in normal individuals using processed MRI derived dynamic small bowel sequences.
Time frame: 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
Time frame: 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.
Time frame: 7 years
To compare dysmotility patients motility to that of normal controls with and in the absence of pro---kinetic agent.
Time frame: 7 years
To establish basal bowel motility reference ranges in a larger cohort of control, dysmotility and irritable bowel syndrome subjects.
Time frame: 7 years
To assess the reversibility of dysmotility after treatment of the primary underlying condition, if known
Time frame: 7 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex Menys contact
Stuart Taylor principal investigator
Centre for Medical Imaging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Motility Disorder of Intestine, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alex Menys (alex.meny.09@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To establish the reproducibility of software quantified small bowel motility in normal individuals using processed MRI derived dynamic small bowel sequences. (time frame: 7 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2016.