Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-01-01 @ 9:05 AM
Study NCT ID:
NCT03566550
Status:
COMPLETED
Last Update Posted:
2021-07-21
First Post:
2018-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Gut Imaging for Function & Transit in Cystic Fibrosis Study 1
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alan.smyth@nottingham.ac.uk', 'phone': '01158230612', 'title': 'Professor Alan Smyth', 'organization': 'University of Nottingham'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 day of MRI scanning', 'eventGroups': [{'id': 'EG000', 'title': 'Cystic Fibrosis', 'description': 'people with cystic fibrosis\n\nMRI scans: Repeated MRI scans imaging digestion of standard meals', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'people without cystic fibrosis\n\nMRI scans: Repeated MRI scans imaging digestion of standard meals', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Orocaecal Transit Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cystic Fibrosis', 'description': 'people with cystic fibrosis\n\nMRI scans: Repeated MRI scans imaging digestion of standard meals'}, {'id': 'OG001', 'title': 'Control', 'description': 'people without cystic fibrosis\n\nMRI scans: Repeated MRI scans imaging digestion of standard meals'}], 'classes': [{'categories': [{'measurements': [{'value': '330', 'comment': 'please note the upper quartile for the cystic fibrosis group states NA due to censored data after 360 minutes (MRI scans were only performed until 360 minutes).', 'groupId': 'OG000', 'lowerLimit': '270', 'upperLimit': 'NA'}, {'value': '210', 'groupId': 'OG001', 'lowerLimit': '173', 'upperLimit': '315'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '1 day of scanning', 'description': 'time taken after eating for ingested food to be identifiable in the caecum on MRI', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gastric Half Emptying Times', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cystic Fibrosis', 'description': 'people with cystic fibrosis\n\nMRI scans: Repeated MRI scans imaging digestion of standard meals'}, {'id': 'OG001', 'title': 'Control', 'description': 'people without cystic fibrosis\n\nMRI scans: Repeated MRI scans imaging digestion of standard meals'}], 'classes': [{'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000', 'lowerLimit': '71', 'upperLimit': '128'}, {'value': '80', 'groupId': 'OG001', 'lowerLimit': '66', 'upperLimit': '88'}]}]}], 'analyses': [{'pValue': '0.3', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '1 day of scanning', 'description': '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)', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Small Bowel Water Content (Corrected for Body Surface Area)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cystic Fibrosis', 'description': 'people with cystic fibrosis\n\nMRI scans: Repeated MRI scans imaging digestion of standard meals'}, {'id': 'OG001', 'title': 'Control', 'description': 'people without cystic fibrosis\n\nMRI scans: Repeated MRI scans imaging digestion of standard meals'}], 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000', 'lowerLimit': '36', 'upperLimit': '80'}, {'value': '34', 'groupId': 'OG001', 'lowerLimit': '28', 'upperLimit': '41'}]}]}], 'analyses': [{'pValue': '0.021', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '1 day of scanning', 'description': '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)', 'unitOfMeasure': 'L.min/m^2', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Colonic Volume (Corrected for Body Surface Area)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cystic Fibrosis', 'description': 'people with cystic fibrosis\n\nMRI scans: Repeated MRI scans imaging digestion of standard meals'}, {'id': 'OG001', 'title': 'Control', 'description': 'people without cystic fibrosis\n\nMRI scans: Repeated MRI scans imaging digestion of standard meals'}], 'classes': [{'categories': [{'measurements': [{'value': '186', 'groupId': 'OG000', 'lowerLimit': '166', 'upperLimit': '206'}, {'value': '123', 'groupId': 'OG001', 'lowerLimit': '89', 'upperLimit': '146'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '1 day of scanning', 'description': '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)', 'unitOfMeasure': 'L.min/m^2', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gastrointestinal Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cystic Fibrosis', 'description': 'people with cystic fibrosis\n\nMRI scans: Repeated MRI scans imaging digestion of standard meals'}, {'id': 'OG001', 'title': 'Control', 'description': 'people without cystic fibrosis\n\nMRI scans: Repeated MRI scans imaging digestion of standard meals'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '25'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '14'}]}]}], 'analyses': [{'pValue': '0.13', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '1 day of scanning', 'description': '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.', 'unitOfMeasure': 'CFAbd-Score units', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'T1 Relaxation Time of Ascending Colon Chyme', 'timeFrame': '1 day of scanning', 'description': 'An approximate measure of water content in chyme present in the ascending colon', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Fat Fraction of the Ascending Colon Chyme', 'timeFrame': '1 day of scanning', 'description': 'A measure of fat content in chyme present in the ascending colon', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cystic Fibrosis', 'description': 'people with cystic fibrosis\n\nMRI scans: Repeated MRI scans imaging digestion of standard meals'}, {'id': 'FG001', 'title': 'Control', 'description': 'people without cystic fibrosis\n\nMRI scans: Repeated MRI scans imaging digestion of standard meals'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '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.\n\n12 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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cystic Fibrosis', 'description': 'people with cystic fibrosis\n\nMRI scans: Repeated MRI scans imaging digestion of standard meals'}, {'id': 'BG001', 'title': 'Control', 'description': 'people without cystic fibrosis\n\nMRI scans: Repeated MRI scans imaging digestion of standard meals'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight (kg)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000', 'lowerLimit': '53', 'upperLimit': '59'}, {'value': '62', 'groupId': 'BG001', 'lowerLimit': '59', 'upperLimit': '75'}, {'value': '59', 'groupId': 'BG002', 'lowerLimit': '54', 'upperLimit': '63'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Height (cm)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '166', 'groupId': 'BG000', 'lowerLimit': '158', 'upperLimit': '175'}, {'value': '166', 'groupId': 'BG001', 'lowerLimit': '160', 'upperLimit': '176'}, {'value': '166', 'groupId': 'BG002', 'lowerLimit': '158', 'upperLimit': '176'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cm', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-01', 'size': 586898, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-01-12T07:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-20', 'studyFirstSubmitDate': '2018-06-12', 'resultsFirstSubmitDate': '2021-01-14', 'studyFirstSubmitQcDate': '2018-06-12', 'lastUpdatePostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-09', 'studyFirstPostDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'T1 Relaxation Time of Ascending Colon Chyme', 'timeFrame': '1 day of scanning', 'description': 'An approximate measure of water content in chyme present in the ascending colon'}, {'measure': 'Fat Fraction of the Ascending Colon Chyme', 'timeFrame': '1 day of scanning', 'description': 'A measure of fat content in chyme present in the ascending colon'}], 'primaryOutcomes': [{'measure': 'Orocaecal Transit Time', 'timeFrame': '1 day of scanning', 'description': 'time taken after eating for ingested food to be identifiable in the caecum on MRI'}], 'secondaryOutcomes': [{'measure': 'Gastric Half Emptying Times', 'timeFrame': '1 day of scanning', 'description': '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)'}, {'measure': 'Small Bowel Water Content (Corrected for Body Surface Area)', 'timeFrame': '1 day of scanning', 'description': '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)'}, {'measure': 'Colonic Volume (Corrected for Body Surface Area)', 'timeFrame': '1 day of scanning', 'description': '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)'}, {'measure': 'Gastrointestinal Symptoms', 'timeFrame': '1 day of scanning', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': "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.\n\nClinical 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.\n\nThe 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.", 'detailedDescription': '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.\n\nParticipants 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.\n\nAfter 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.\n\nThey 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.\n\nInfection 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Nottingham and surrounding towns', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 12 - 40 years\n* Capacity to consent, or to understand the requirements of the study where parental consent is needed\n* PATIENTS: confirmed diagnosis of Cystic Fibrosis, either by sweat test or genetic testing; to reduce heterogeneity, we will only enrol homozygous CF patients with the most common CFTR mutation, p.Phe508del\n* CONTROLS: no clinical evidence or suspicion of Cystic Fibrosis\n\nExclusion Criteria:• Measurement of Forced Expiratory Volume in 1 second (FEV1) of \\<40% predicted using Global Lung Initiative criteria, according to clinical records\n\n* Contra-indication to MRI scanning, such as embedded metal, pacemaker\n* Unable to stop medications directly prescribed to alter bowel habit, such as laxatives of anti-diarrhoeals, on the study day\n* Previous resection of any part of the gastro-intestinal tract apart from appendicectomy or cholecystectomy. Surgical relief of distal ileal obstruction syndrome or neonatal ileus will be permitted unless clinical records show excision of intestine \\>20cm in length.\n* Intestinal stoma\n* Diagnosis of inflammatory bowel disease or coeliac disease confirmed by biopsy\n* Gastrointestinal malignancy\n* Unable to comply with dietary restrictions required for the study'}, 'identificationModule': {'nctId': 'NCT03566550', 'acronym': 'GIFT-CF1', 'briefTitle': 'Gut Imaging for Function & Transit in Cystic Fibrosis Study 1', 'organization': {'class': 'OTHER', 'fullName': 'Nottingham University Hospitals NHS Trust'}, 'officialTitle': 'A Case-Control, Observational Study of the Postprandial Changes in Magnetic Resonance Imaging Parameters of Gastrointestinal Function and Transit in People With Cystic Fibrosis', 'orgStudyIdInfo': {'id': '18GA006'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CF', 'description': 'people with cystic fibrosis', 'interventionNames': ['Diagnostic Test: MRI scans']}, {'label': 'Control', 'description': 'people without cystic fibrosis', 'interventionNames': ['Diagnostic Test: MRI scans']}], 'interventions': [{'name': 'MRI scans', 'type': 'DIAGNOSTIC_TEST', 'description': 'Repeated MRI scans imaging digestion of standard meals', 'armGroupLabels': ['CF', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG7 2UH', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospitals National Health Service Trust', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Alan Smyth, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nottingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share individual participant data outside the research team at this time.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nottingham University Hospitals NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}