NCT04193735

Pseudo-obstruction Assessment With MRI

A Case-control Study of the Gastrointestinal Response to a Liquid Test Meal in Chronic Intestinal Pseudo-obstruction, Using Magnetic Resonance Imaging

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 16 (estimated)
• Sponsor: University of Nottingham · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Chronic Intestinal Pseudo-Obstruction

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-01-17
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2019-12-10
• Last updated: 2024-02-07

Locations

1 site across 1 country: United Kingdom