Cystic FibrosisGIFT-CF1NCT03566550
Gut Imaging for Function & Transit in Cystic Fibrosis Study 1
An observational study of Cystic Fibrosis, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- MRI scans
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Sep 2018to 20 Feb 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Nottingham and surrounding towns
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Hospitals National Health Service Trust
Nottingham, NG7 2UH
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Cystic Fibrosis
- Being tested
- MRI scans
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scansDiagnostic test
Repeated MRI scans imaging digestion of standard meals
| Study group | Role | What they receive |
|---|---|---|
| CF | people with cystic fibrosis Receives: Diagnostic Test: MRI scans | |
| Control | people without cystic fibrosis Receives: Diagnostic Test: MRI scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orocaecal Transit Time
time taken after eating for ingested food to be identifiable in the caecum on MRI
Measured: 1 day of scanning
Secondary outcomes (4)
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)
Measured: 1 day of scanning
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)
Measured: 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)
Measured: 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.
Measured: 1 day of scanning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start4 Sep 2018
- Primary completion20 Feb 2019
- Study completion20 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan Smyth, Prof, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03566550
- Sponsor's protocol ID
- 18GA006
- Acronym
- GIFT-CF1
- Status last verified
- Jul 2021
- First submitted
- 12 Jun 2018
- Last updated
- 21 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data outside the research team at this time.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03566550
- Acronym / sponsor ID
- GIFT-CF1 / 18GA006
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 20 Feb 2019 (actual)
- First posted
- 25 Jun 2018 (actual)
- Results
- Posted 5 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CF | – | Diagnostic Test: MRI scanspeople with cystic fibrosis |
| Control | – | Diagnostic Test: MRI scanspeople without cystic fibrosis |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Nottingham and surrounding towns
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI scansRepeated MRI scans imaging digestion of standard meals | Diagnostic test | CF, Control |
Primary outcome
Orocaecal Transit Time
Time frame: 1 day of scanning
time taken after eating for ingested food to be identifiable in the caecum on MRI
4 secondary outcomes
Gastric Half Emptying Times
Time frame: 1 day of scanning
Small Bowel Water Content (Corrected for Body Surface Area)
Time frame: 1 day of scanning
Colonic Volume (Corrected for Body Surface Area)
Time frame: 1 day of scanning
Gastrointestinal Symptoms
Time frame: 1 day of scanning
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data outside the research team at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Smyth, Prof principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orocaecal Transit Time (time frame: 1 day of scanning). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021; AzTrials last refreshed its copy on 1 Nov 2026.