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Many people with Cystic Fibrosis (CF) are troubled by symptoms from their stomach and bowels: their gastrointestinal (GI) tract. Symptoms affect quality of life and can also reduce people's ability to digest enough calories to remain healthy, leaving them undernourished and less able to deal with other health problems such as infection.
Clinical tests to assess bowel function are limited. Many tests involve inserting a sensor or camera into the bowel, so they are not suitable for long periods, and can be uncomfortable. In Nottingham the investigators have developed imaging scans which can assess how someone's digestion works without any invasive device. The type of scanning the investigators use is called Magnetic Resonance Imaging, or MRI.
The purpose of this study is to see if those scanning methods can be used in people with CF to understand their digestion and any problems they have.
This is a small pilot study to establish that differences in digestion between people with and without CF can be quantified by repeated MR scans in fasted participants in response to standardised meals.
Participants will complete questionnaires on gastrointestinal function and symptoms: the PAC-SYM questionnaire, validated to assess symptom burden in adults with chronic constipation; and the CF abdomen questionnaire, developed in German for use in young people and adults with cystic fibrosis.
After this, participants only need to attend one study day at the Sir Peter Mansfield Imaging Centre. On this day they will be asked to withhold any medicines specifically targeted to alter bowel habit. This shall include laxatives but not enzyme replacement therapy. They should attend on the study day having fasted since waking, other than water for essential medicines.
They will have their first MRI scan fasted. After the scan they will eat a standard test meal, and be scanned again first at half hour, then hour intervals until six hours after the first meal. The final scan will constitute the end of the study for each participant. Each session in the MRI scanner will last around 15 minutes. After each scan they will complete a validated rating scale for any current symptoms: the Gastrointestinal Symptom Rating Scale (GSRS).In between scans, participants will have access to a lounge with wifi and a television.
Infection control requirements mean that the investigators are unable to scan more than one patient with CF on a single day. Patient scans will alternate with those of a Control participant. The investigators will aim to frequency match Controls with Patients for age and gender.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CF | people with cystic fibrosis |
| |
| Control | people without cystic fibrosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI scans | Diagnostic Test | Repeated MRI scans imaging digestion of standard meals |
|
| Measure | Description | Time Frame |
|---|---|---|
| Orocaecal Transit Time | time taken after eating for ingested food to be identifiable in the caecum on MRI | 1 day of scanning |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric Half Emptying Times | volume of stomach at each time point of digestion to measure speed of gastric emptying (time taken for half the gastric contents to be emptied) | 1 day of scanning |
| Small Bowel Water Content (Corrected for Body Surface Area) |
| Measure | Description | Time Frame |
|---|---|---|
| T1 Relaxation Time of Ascending Colon Chyme | An approximate measure of water content in chyme present in the ascending colon | 1 day of scanning |
| Fat Fraction of the Ascending Colon Chyme | A measure of fat content in chyme present in the ascending colon |
Inclusion Criteria:
Exclusion Criteria:• Measurement of Forced Expiratory Volume in 1 second (FEV1) of <40% predicted using Global Lung Initiative criteria, according to clinical records
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Nottingham and surrounding towns
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| Name | Affiliation | Role |
|---|---|---|
| Alan Smyth, Prof | University of Nottingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nottingham University Hospitals National Health Service Trust | Nottingham | NG7 2UH | United Kingdom |
There is no plan to share individual participant data outside the research team at this time.
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51 CF patients were eligible. CF patients were approached in order of their hospital attendance and the first 12 to provide written consent were enroled into the study. 13 declined to participate and 2 withdrew consent as they did not like the standardised meals or MRI.
12 CF patients and 12 controls completed the protocol without any adverse events. 1 further control was withdrawn and replaced as the participant was unable to complete the first standardised meal and the remaining 10 MRI scans.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cystic Fibrosis | people with cystic fibrosis MRI scans: Repeated MRI scans imaging digestion of standard meals |
| FG001 | Control | people without cystic fibrosis MRI scans: Repeated MRI scans imaging digestion of standard meals |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cystic Fibrosis | people with cystic fibrosis MRI scans: Repeated MRI scans imaging digestion of standard meals |
| BG001 | Control | people without cystic fibrosis MRI scans: Repeated MRI scans imaging digestion of standard meals |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Orocaecal Transit Time | time taken after eating for ingested food to be identifiable in the caecum on MRI | Posted | Median | Inter-Quartile Range | minutes | 1 day of scanning |
|
|
1 day of MRI scanning
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cystic Fibrosis | people with cystic fibrosis MRI scans: Repeated MRI scans imaging digestion of standard meals |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Alan Smyth | University of Nottingham | 01158230612 | alan.smyth@nottingham.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2018 | Jan 12, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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volume of water content in small bowel representing secretions (area under the curve - timepoints at baseline then 0,30,60,90,120,150,180,240,300,360 minutes) |
| 1 day of scanning |
| Colonic Volume (Corrected for Body Surface Area) | volume of colon representing ease of chyme passage through colon (area under the curve - timepoints at baseline then 0,30,60,90,120,150,180,240,300,360 minutes) | 1 day of scanning |
| Gastrointestinal Symptoms | gastrointestinal symptoms as measured by questionnaires to monitor relationship with outcomes measured by MRI. Scale of the CFAbd-score ranges from 0-100. A low score indicates fewer gastrointestinal symptoms whilst a higher score indicates more severe and frequent gastrointestinal symptoms. | 1 day of scanning |
| 1 day of scanning |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight (kg) | Median | Inter-Quartile Range | kg |
|
| Height (cm) | Median | Inter-Quartile Range | cm |
|
| Participants |
|
|
|
| Secondary | Gastric Half Emptying Times | volume of stomach at each time point of digestion to measure speed of gastric emptying (time taken for half the gastric contents to be emptied) | Posted | Median | Inter-Quartile Range | minutes | 1 day of scanning |
|
|
|
|
| Secondary | Small Bowel Water Content (Corrected for Body Surface Area) | volume of water content in small bowel representing secretions (area under the curve - timepoints at baseline then 0,30,60,90,120,150,180,240,300,360 minutes) | Posted | Median | Inter-Quartile Range | L.min/m^2 | 1 day of scanning |
|
|
|
|
| Secondary | Colonic Volume (Corrected for Body Surface Area) | volume of colon representing ease of chyme passage through colon (area under the curve - timepoints at baseline then 0,30,60,90,120,150,180,240,300,360 minutes) | Posted | Median | Inter-Quartile Range | L.min/m^2 | 1 day of scanning |
|
|
|
|
| Secondary | Gastrointestinal Symptoms | gastrointestinal symptoms as measured by questionnaires to monitor relationship with outcomes measured by MRI. Scale of the CFAbd-score ranges from 0-100. A low score indicates fewer gastrointestinal symptoms whilst a higher score indicates more severe and frequent gastrointestinal symptoms. | Posted | Median | Inter-Quartile Range | CFAbd-Score units | 1 day of scanning |
|
|
|
|
| Other Pre-specified | T1 Relaxation Time of Ascending Colon Chyme | An approximate measure of water content in chyme present in the ascending colon | Not Posted | 1 day of scanning | Participants |
| Other Pre-specified | Fat Fraction of the Ascending Colon Chyme | A measure of fat content in chyme present in the ascending colon | Not Posted | 1 day of scanning | Participants |
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Control | people without cystic fibrosis MRI scans: Repeated MRI scans imaging digestion of standard meals | 0 | 12 | 0 | 12 | 0 | 12 |
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |