Cystic Fibrosis Clinical Trial
— GIFT-CF1Official title:
A Case-Control, Observational Study of the Postprandial Changes in Magnetic Resonance Imaging Parameters of Gastrointestinal Function and Transit in People With Cystic Fibrosis
NCT number | NCT03566550 |
Other study ID # | 18GA006 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 4, 2018 |
Est. completion date | February 20, 2019 |
Verified date | July 2021 |
Source | Nottingham University Hospitals NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | February 20, 2019 |
Est. primary completion date | February 20, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 40 Years |
Eligibility | Inclusion Criteria: - Age 12 - 40 years - Capacity to consent, or to understand the requirements of the study where parental consent is needed - 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 - CONTROLS: no clinical evidence or suspicion of Cystic Fibrosis Exclusion Criteria:• Measurement of Forced Expiratory Volume in 1 second (FEV1) of <40% predicted using Global Lung Initiative criteria, according to clinical records - Contra-indication to MRI scanning, such as embedded metal, pacemaker - Unable to stop medications directly prescribed to alter bowel habit, such as laxatives of anti-diarrhoeals, on the study day - 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. - Intestinal stoma - Diagnosis of inflammatory bowel disease or coeliac disease confirmed by biopsy - Gastrointestinal malignancy - Unable to comply with dietary restrictions required for the study |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Nottingham University Hospitals National Health Service Trust | Nottingham |
Lead Sponsor | Collaborator |
---|---|
Nottingham University Hospitals NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | T1 Relaxation Time of Ascending Colon Chyme | An approximate measure of water content in chyme present in the ascending colon | 1 day of scanning | |
Other | Fat Fraction of the Ascending Colon Chyme | A measure of fat content in chyme present in the ascending colon | 1 day of scanning | |
Primary | Orocaecal Transit Time | time taken after eating for ingested food to be identifiable in the caecum on MRI | 1 day of scanning | |
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) | 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) | 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) | 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. | 1 day of scanning |
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