Pseudo-obstruction Assessment With MRI

Last updated: February 6, 2024
Sponsor: University of Nottingham
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ileus

Bowel Dysfunction

Irritable Bowel Syndrome (Ibs)

Treatment

MRI scans after a liquid meal

Clinical Study ID

NCT04193735
19069
  • Ages > 16
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Inability to tolerate 400 ml liquid challenge meal (oral or through establishedgastrostomy; 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, suchas antiemetics, fast release opioids, laxatives, and anti-diarrhoeals, on the daybefore the study (24h before baseline scan; i.e. a total of circa 30h) as well asantibiotics for three days before the study. This only applies to long-termantibiotics commonly given for dysbiosis (small intestinal bacterial overgrowth). Ashort course of antibiotics given for acute infections will not be interrupted but thestudy day will be delayed until the course is finished. Patches, long actingformulations such as slow release medication or depot injection medication will beallowed to continue
  • Inability to omit parenteral nutrition for 12 hours before the fasting MRI scan (~16htotal)
  • Medical comorbidity that means subject will not be able to undergo multiple scans e.g.severe respiratory disorder limiting time lying flat; severe musculoskeletal disorderlimiting mobility
  • Previous small bowel resection (excluding ileostomy, insertion of venting tube orpercutaneous endoscopic gastrostomy, appendectomy or cholecystectomy). Patients whohave had a colectomy for their CIPO will be eligible.
  • Other gastrointestinal disorder likely to alter small bowel function e.g. uncontrolledcoeliac disease, Crohn's disease. A diagnosis of small intestinal bacterial overgrowthwill not be a reason for exclusion. PICs will be asked to supply information onresections and comorbidities for CIPO participants.

Study Design

Total Participants: 16
Treatment Group(s): 1
Primary Treatment: MRI scans after a liquid meal
Phase:
Study Start date:
January 17, 2020
Estimated Completion Date:
December 30, 2024

Study 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.

Connect with a study center

  • University of Nottingham

    Nottingham, Nottinghamshire NG7 2RD
    United Kingdom

    Active - Recruiting

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