Chronic Intestinal Pseudo-ObstructionPOMNCT04193735
Pseudo-obstruction Assessment With MRI
An observational study of Chronic Intestinal Pseudo-Obstruction, run by University of Nottingham at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Chronic Intestinal Pseudo-Obstruction
- What is being tested?
- MRI scans after a liquid meal
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Jan 2020to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cases will be recruited through Digestive Diseases clinical services across England; Controls will be recruited from the population of Nottingham.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Nottingham
Nottingham, Nottinghamshire, NG7 2RD
About this study
Official title: A Case-control Study of the Gastrointestinal Response to a Liquid Test Meal in Chronic Intestinal Pseudo-obstruction, Using Magnetic Resonance Imaging
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).
Read the 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
- Being tested
- MRI scans after a liquid meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scans after a liquid mealDiagnostic test
Participants will be scanned fasted, then receive a liquid meal, then be scanned every half hour, seven times
| Study group | Role | What they receive |
|---|---|---|
| CIPO (case) | MRI scan of gastrointestinal content and activity Receives: Diagnostic Test: MRI scans after a liquid meal | |
| Chronic constipation (control) | MRI scan of gastrointestinal content and activity Receives: Diagnostic Test: MRI scans after a liquid meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 3.5 hours after meal, measured every half hour
Secondary outcomes (3)
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.
Measured: up to 3.5 hours after meal, measured every half hour
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.
Measured: 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).
Measured: up to 3.5 hours after meal, measured every half hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start17 Jan 2020
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Intestinal Pseudo-ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Pseudo-Obstruction Research Trust, Northern Care Alliance 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
- Responsible party
- Sponsor
- Investigators
- Giles Major, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193735
- Sponsor's protocol ID
- 19069
- Acronym
- POM
- Status last verified
- Feb 2024
- First submitted
- 22 Nov 2019
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case-control Study of the Gastrointestinal Response to a Liquid Test Meal in Chronic Intestinal Pseudo-obstruction, Using Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT04193735
- Acronym / sponsor ID
- POM / 19069
- Conditions
- Chronic Intestinal Pseudo-Obstruction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Pseudo-Obstruction Research Trust, Northern Care Alliance 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
- Study start
- 17 Jan 2020 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIPO (case) | – | Diagnostic Test: MRI scans after a liquid mealMRI scan of gastrointestinal content and activity |
| Chronic constipation (control) | – | Diagnostic Test: MRI scans after a liquid mealMRI scan of gastrointestinal content and activity |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cases will be recruited through Digestive Diseases clinical services across England; Controls will be recruited from the population of Nottingham.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI scans after a liquid mealParticipants will be scanned fasted, then receive a liquid meal, then be scanned every half hour, seven times | Diagnostic test | CIPO (case), Chronic constipation (control) |
Primary outcome
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.
3 secondary outcomes
Gastric emptying rate (ml/min) after a test liquid meal
Time frame: up to 3.5 hours after meal, measured every half hour
Small bowel water volume (ml) after a test liquid meal
Time frame: up to 3.5 hours after meal, measured every half hour
Gastric motility after a test liquid meal
Time frame: up to 3.5 hours after meal, measured every half hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giles Major, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Intestinal Pseudo-Obstruction, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giles Major, PhD (+44 115 8231035, giles.major@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak small gut motility after a test liquid meal (time frame: up to 3.5 hours after meal, measured every half hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.