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| Name | Class |
|---|---|
| Pseudo-Obstruction Research Trust | UNKNOWN |
| Northern Care Alliance NHS Foundation Trust | OTHER |
| Manchester University NHS Foundation Trust | OTHER_GOV |
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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CIPO (case) | MRI scan of gastrointestinal content and activity |
| |
| Chronic constipation (control) | MRI scan of gastrointestinal content and activity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric emptying rate (ml/min) after a test liquid meal | 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. | up to 3.5 hours after meal, measured every half hour |
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Inclusion Criteria:
Exclusion Criteria:
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Cases will be recruited through Digestive Diseases clinical services across England; Controls will be recruited from the population of Nottingham.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giles Major, PhD | Contact | +44 115 8231035 | giles.major@nottingham.ac.uk | |
| Neele Dellschaft, PhD | Contact | +44 115 8467774 | neele.dellschaft@nottingham.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Giles Major, PhD | University of Nottingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nottingham | Recruiting | Nottingham | Nottinghamshire | NG7 2RD | United Kingdom |
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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| Cambridge University Hospitals NHS Foundation Trust |
| OTHER |
| Oxford University Hospitals NHS Trust | OTHER |
| Barts & The London NHS Trust | OTHER |
| London North West Healthcare NHS Trust | OTHER |
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| Small bowel water volume (ml) after a test liquid meal | 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. | up to 3.5 hours after meal, measured every half hour |
| Gastric motility after a test liquid meal | 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). | up to 3.5 hours after meal, measured every half hour |