Pseudo-obstruction Assessment With MRI

NCT04193735 | Recruiting

• 1 other identifier: 19069
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Intestinal Pseudo-Obstruction

Outcome Measures

Primary Outcomes (1)

• Peak small gut motility after a test liquid meal

  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.

  up to 3.5 hours after meal, measured every half hour

Secondary Outcomes (3)

• Gastric emptying rate (ml/min) after a test liquid meal

  up to 3.5 hours after meal, measured every half hour

• Small bowel water volume (ml) after a test liquid meal

  up to 3.5 hours after meal, measured every half hour

• Gastric motility after a test liquid meal

  up to 3.5 hours after meal, measured every half hour

Study Arms (2)

CIPO (case)

MRI scan of gastrointestinal content and activity

Diagnostic Test: MRI scans after a liquid meal

Chronic constipation (control)

MRI scan of gastrointestinal content and activity

Diagnostic Test: MRI scans after a liquid meal

Interventions

MRI scans after a liquid meal DIAGNOSTIC_TEST

Participants will be scanned fasted, then receive a liquid meal, then be scanned every half hour, seven times

CIPO (case); Chronic constipation (control)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nottingham: lead
• Pseudo-Obstruction Research Trust: collaborator
• Northern Care Alliance NHS Foundation Trust: collaborator
• Manchester University NHS Foundation Trust: collaborator
• Cambridge University Hospitals NHS Foundation Trust: collaborator
• Oxford University Hospitals NHS Trust: collaborator
• Barts & The London NHS Trust: collaborator
• London North West Healthcare NHS Trust: collaborator

Study Sites (1)

University of Nottingham

Nottingham, Nottinghamshire, NG7 2RD, United Kingdom

RECRUITING

Study Officials

• Giles Major, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giles Major, PhD

CONTACT

+44 115 8231035; giles.major@nottingham.ac.uk

Neele Dellschaft, PhD

CONTACT

+44 115 8467774; neele.dellschaft@nottingham.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: December 10, 2019
• Study Start: January 17, 2020
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)