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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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5 June 2023 |
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Main ID: |
NCT04006873 |
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Date of registration:
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02/07/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Gut Imaging for Function & Transit in Cystic Fibrosis Study 2
GIFT-CF2 |
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Scientific title:
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A Randomised Crossover Pilot Study of the Effects of Tezacaftor/Ivacaftor and Ivacaftor on Gastrointestinal Function Using Magnetic Resonance Imaging Parameters in People With Cystic Fibrosis |
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Date of first enrolment:
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September 3, 2019 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT04006873 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Giles Major, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Nottingham |
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Name:
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Alan Smyth, Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Nottingham |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- capacity to consent, or to understand the requirements of the study where parental
consent is needed
- confirmed diagnosis of CF, either by sweat test or genetic testing.
Tezacaftor/Ivacaftor is indicated only for patients homozygous for the commonest CF
mutation - p.Phe508del and so we will enrol only CF patients with this genotype
Exclusion Criteria:
- currently taking CFTR modulator drug
- Contra-indication to use of Tezacaftor/Ivacaftor
- Measurement of FEV1 <40% predicted using Global Lung Initiative criteria, according to
clinical records, as participants will be required to perform a series of 10 second
breathholds throughout MRI scanning
- Contra-indication to MRI scanning, such as embedded metal, pacemaker.
- Pregnancy
- Unable to stop medications directly prescribed to alter bowel habit, such as laxatives
or anti-diarrhoeals, on the study day
- Previous resection of any part of the gastrointestinal tract apart from appendicectomy
or cholecystectomy. Surgical relief of meconium ileus or DIOS 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.
Age minimum:
12 Years
Age maximum:
40 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: Placebo oral tablet
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Drug: Tezacaftor/Ivacaftor + Ivacaftor
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Primary Outcome(s)
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Oro-caecal Transit Time
[Time Frame: 1 day of scanning]
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Secondary Outcome(s)
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Gastric volume
[Time Frame: 1 day of scanning]
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Colonic volume (corrected for body surface area)
[Time Frame: 1 day of scanning]
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Small bowel water content (corrected for body surface area)
[Time Frame: 1 day of scanning]
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Gastrointestinal symptoms
[Time Frame: 1 day of scanning]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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