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Pseudo-obstruction Assessment With MRI (POM)

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ClinicalTrials.gov Identifier: NCT04193735
Recruitment Status : Recruiting
First Posted : December 10, 2019
Last Update Posted : April 29, 2021
Sponsor:
Collaborators:
Pseudo-Obstruction Research Trust
Salford Royal NHS Foundation Trust
Manchester University NHS Foundation Trust
Cambridge University Hospitals NHS Foundation Trust
Oxford University Hospitals NHS Trust
Barts & The London NHS Trust
London North West Healthcare NHS Trust
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:
This study will explore the potential for a standardized MRI scan after a liquid meal to be used in diagnosis of the rare but debilitating chronic intestinal pseudo-obstruction (CIPO).

Condition or disease Intervention/treatment
Chronic Intestinal Pseudo-Obstruction Diagnostic Test: MRI scans after a liquid meal

Detailed Description:

People with chronic intestinal pseudo-obstruction (CIPO) have problems digesting their food properly, due to a problem in their gut nerves or muscle. There are not many good tests to assess how a patient's stomach and bowels are working. Finding out more is the first step in developing a standardized clinical test using MRI to provide a faster diagnosis than is currently possible. Magnetic resonance imaging (MRI) scans allow the investigators to see inside the abdomen. Scans are not painful or harmful and are therefore ideal for repeated measurements. By scanning participants both before and after a test drink the investigators can see exactly how their digestion is working.

The investigators are inviting 16 people who are at least 16 years old, 8 who have CIPO and 8 with chronic constipation, so the investigators can compare the images. Participants will come in for one half day of scanning. The investigators will take a total of 8 scans of their abdomens, every half hour. Participants will also fill in symptom questionnaires at every scan, for example if they feel bloated or have any abdominal pain. Each scan will take about 15 minutes and will require short breath holds. Participants will be able to get out of the scanner at any time point if they feel the need to.

Participants will arrive fasted in the morning and will receive a test drink (a milk-based drink used as an oral nutritional supplement) right after the first scan. All participants will be asked to pause some of their usual medication that has a direct influence on digestion for 24h before the scan day and during the ~4h of the study.

The primary outcome is peak small bowel motility, which the investigators hypothesize to be less active in people with CIPO. Other outcomes include gastric volume, small bowel water content and distribution, peak gastric motility, and gastrointestinal symptoms.

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Study Type : Observational
Estimated Enrollment : 16 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: A Case-control Study of the Gastrointestinal Response to a Liquid Test Meal in Chronic Intestinal Pseudo-obstruction, Using Magnetic Resonance Imaging
Actual Study Start Date : January 17, 2020
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021


Group/Cohort Intervention/treatment
CIPO (case)
MRI scan of gastrointestinal content and activity
Diagnostic Test: MRI scans after a liquid meal
Participants will be scanned fasted, then receive a liquid meal, then be scanned every half hour, seven times

Chronic constipation (control)
MRI scan of gastrointestinal content and activity
Diagnostic Test: MRI scans after a liquid meal
Participants will be scanned fasted, then receive a liquid meal, then be scanned every half hour, seven times




Primary Outcome Measures :
  1. Peak small gut motility after a test liquid meal [ Time Frame: up to 3.5 hours after meal, measured every half hour ]
    Investigating whether people with CIPO have a lower peak small gut motility after a test drink than people who do not have CIPO. Small gut motility will be assessed with a standardised method on CineMRI, based on power spectrum analysis of voxel-signal changes with time (the outcome will be reported in arbitrary units). The primary outcome is peak small gut motility since a delay in motility (linked to one specific time point) would not be sufficient to explain the difference between CIPO and controls.


Secondary Outcome Measures :
  1. Gastric emptying rate (ml/min) after a test liquid meal [ Time Frame: up to 3.5 hours after meal, measured every half hour ]
    Investigating whether people with CIPO have slower gastric emptying after a test drink than people who do not have CIPO. The gastric emptying rate is determined by measuring the gastric volume every half hour after the standardised meal.

  2. Small bowel water volume (ml) after a test liquid meal [ Time Frame: up to 3.5 hours after meal, measured every half hour ]
    Investigating whether people with CIPO have a greater volume of small bowel water after a test drink than people who do not have CIPO. Small bowel water content is determined from a heavily T2-weighted scan. The intensity threshold for free water will be set using each participant's spinal fluid, and only small bowel contents having an intensity equal to or greater than this value will be measured as small bowel free water volume.

  3. Gastric motility after a test liquid meal [ Time Frame: up to 3.5 hours after meal, measured every half hour ]
    Investigating whether people with CIPO have a reduced gastric motility after a test drink than people who do not have CIPO. Gastric motility will be assessed with a standardised method on CineMRI, based on power spectrum analysis of voxel-signal changes with time (the outcome will be reported in arbitrary units).



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cases will be recruited through Digestive Diseases clinical services across England; Controls will be recruited from the population of Nottingham.
Criteria

Inclusion Criteria:

  • Ability to give informed consent
  • Sufficient level of English language to understand study information and respond to symptom questionnaires
  • CASES: a clinical diagnosis of primary or secondary Chronic Intestinal Pseudo-Obstruction, excluding adhesional obstruction. PICs will be asked to send clinical documentation that the diagnosis has been confirmed on crosssectional imaging.
  • CONTROLS: a Chronic constipation disorder diagnosed according to Rome IV criteria for functional constipation, constipation-predominant irritable bowel syndrome or opioid-induced constipation (diagnostic criteria as listed in Lacy et al 2016)

Exclusion Criteria:

  • Inability to tolerate 400 ml liquid challenge meal (oral or through established gastrostomy; according to self-assessment)
  • Contra-indication to MRI scanning, such as metal implants, pacemaker etc
  • Pregnancy declared by candidate (no formal testing)
  • Inability to stop short-acting medications likely to alter small bowel motility, such as antiemetics, fast release opioids, laxatives, and anti-diarrhoeals, on the day before the study (24h before baseline scan; i.e. a total of circa 30h) as well as antibiotics for three days before the study. This only applies to long-term antibiotics commonly given for dysbiosis (small intestinal bacterial overgrowth). A short course of antibiotics given for acute infections will not be interrupted but the study day will be delayed until the course is finished. Patches, long acting formulations such as slow release medication or depot injection medication will be allowed to continue
  • Inability to omit parenteral nutrition for 12 hours before the fasting MRI scan (~16h total)
  • Medical comorbidity that means subject will not be able to undergo multiple scans e.g. severe respiratory disorder limiting time lying flat; severe musculoskeletal disorder limiting mobility
  • Previous small bowel resection (excluding ileostomy, insertion of venting tube or percutaneous endoscopic gastrostomy, appendectomy or cholecystectomy). Patients who have had a colectomy for their CIPO will be eligible.
  • Other gastrointestinal disorder likely to alter small bowel function e.g. uncontrolled coeliac disease, Crohn's disease. A diagnosis of small intestinal bacterial overgrowth will not be a reason for exclusion. PICs will be asked to supply information on resections and comorbidities for CIPO participants.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04193735


Contacts
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Contact: Giles Major, PhD +44 115 8231035 giles.major@nottingham.ac.uk
Contact: Neele Dellschaft, PhD +44 115 8467774 neele.dellschaft@nottingham.ac.uk

Locations
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United Kingdom
University of Nottingham Recruiting
Nottingham, Nottinghamshire, United Kingdom, NG7 2RD
Sponsors and Collaborators
University of Nottingham
Pseudo-Obstruction Research Trust
Salford Royal NHS Foundation Trust
Manchester University NHS Foundation Trust
Cambridge University Hospitals NHS Foundation Trust
Oxford University Hospitals NHS Trust
Barts & The London NHS Trust
London North West Healthcare NHS Trust
Investigators
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Principal Investigator: Giles Major, PhD University of Nottingham
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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT04193735    
Other Study ID Numbers: 19069
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Anonymised IPD may be available for sharing as part of collaborative data pooling but will not automatically be published as open source due to the possibility of identification through meta-data in a rare disease.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intestinal Pseudo-Obstruction
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases