Gut Imaging for Function & Transit in Cystic Fibrosis Study 2 (GIFT-CF2)
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|ClinicalTrials.gov Identifier: NCT04006873|
Recruitment Status : Not yet recruiting
First Posted : July 3, 2019
Last Update Posted : July 9, 2019
People with Cystic Fibrosis (CF) have problems digesting their food properly. More than 8 in 10 people with CF must take medication to assist their digestion. In spite of this, complications such as bowel blockage occur.
Finding out how already licenced drugs for CF work in the gut is the first step in repurposing medications. Tezacaftor/Ivacaftor with Ivacaftor is a drug combination which corrects the basic defect in CF an has shown improvements on lung function.
The purpose of this study is to evaluate, using Magnetic Resonance Imaging (MRI) and patient-reported outcomes, whether Tezacaftor/Ivacaftor with Ivacaftor has an effect on improving gastrointestinal problems in CF.
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Drug: Tezacaftor/Ivacaftor + Ivacaftor Drug: Placebo oral tablet||Phase 2|
This is a small pilot study to compare the effects of active drug (Tezacaftor/Ivacaftor with Ivacaftor) on the gut in people with CF.
Participants will be randomised to take active drug or matched placebo for 28 days then switch to the alternate drug after a 28 day washout period. Before participants commence treatment, they will have blood pressure and baseline blood tests.
Participants will attend once per treatment period for MRI scanning at the Sir Peter Mansfield Imaging Centre, after an overnight fast. On this day, participants will be asked to withhold any medicines directly altering bowel habit such as laxatives. They will continue to take pancreatic enzyme replacement therapy and other medications for CF.
The Investigators will use the same MRI protocol as described in GIFT-CF (NCT03566550). Participants will have their first MRI scan fasted. After the first scan, they will eat a first standardised meal . They will then have 7 MRI scans at half hourly intervals and 3 MRI scans at hourly intervals. Participants will be given a second standardised meal after their ninth MRI scan. Each MRI scan will last approximately 15 minutes. After each MRI scan, participants will complete a validated gastrointestinal symptom questionnaire (Gastrointestinal Symptom Rating Scale). In between scans, participants will have access to an adjacent room with Wifi and television access.
During the day, participants will have their lung function, blood pressure and blood tests taken. They will also provide a sputum and stool sample.
Infection control requirements mean that only 1 participant will attend for MRI scanning per day.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||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|
|Estimated Study Start Date :||July 2019|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
Active Comparator: Tezacaftor/Ivacaftor in combination with Ivacaftor
A film-coated tablet containing 100mg tezacaftor and 150mg ivacaftor will be taken in the morning.
A film-coated tablet containing 150mg ivacaftor will be taken in the evening.
Participants will take these tablets for 28 days.
All tablets are licensed for use in the EU.
Drug: Tezacaftor/Ivacaftor + Ivacaftor
As per description in arms.
Placebo Comparator: Placebo
A visually matched placebo to the active drugs will be taken in the morning and in the evening for 28 days.
Drug: Placebo oral tablet
As per description in arms
Other Name: Matching placebo tablets
- Oro-caecal Transit Time [ Time Frame: 1 day of scanning ]Time taken after eating for ingested food to be identifiable at the caecum on MRI
- Gastric volume [ Time Frame: 1 day of scanning ]Volume of stomach at each time point of digestion to measure gastric emptying time
- Small bowel water content [ Time Frame: 1 day of scanning ]Volume of water content in small bowel representing secretions
- Colonic volume [ Time Frame: 1 day of scanning ]Volume of colon representing ease of chyme passage through colon
- Gastrointestinal symptoms [ Time Frame: 1 day of scanning ]Gastrointestinal symptoms measured by patient reported outcomes to monitor relationships with outcomes measure by MRI
- Sigmoid colon volume [ Time Frame: 1 day of scanning ]Volume of sigmoid colon
- T1 relaxation of ascending colon chyme [ Time Frame: 1 day of scanning ]An approximate measure of water content in chyme present in the ascending colon
- Fat fraction of ascending colon chyme [ Time Frame: 1 day of scanning ]A measure of fat content in chyme present in the ascending colon
- Faecal elastase [ Time Frame: 1 day ]A measure of elastase in stool to evaluate pancreatic function
- Sputum and faecal microbiome [ Time Frame: 1 day ]A measure of microbiome in sputum and stool
- Faecal calprotectin [ Time Frame: 1 day ]A measure of intestinal inflammation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04006873
|Contact: Christabella Ng, Dr||0115 email@example.com|
|Contact: Giles Major, Dr||0115 firstname.lastname@example.org|
|Nottingham University Hospitals NHS Trust||Not yet recruiting|
|Nottingham, Nottinghamshire, United Kingdom, NG7 2UH|
|Principal Investigator:||Alan Smyth, Prof||University of Nottingham|
|Principal Investigator:||Giles Major, Dr||University of Nottingham|