Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT05934656
Eligibility Criteria:
Inclusion Criteria:
1. Confirmed diagnosis of cystic fibrosis (clinical features of CF combined with either a genotype known to be associated with CF or a diagnostic sweat chloride).
2. For participants enrolled in group A via the mobile phone app, self-reported diagnosis will be accepted.
3. Adult patients will be aged 16 years and over and attend the Nottingham or Leeds CF Centres.
4. Paediatric patients will be aged 6-15 years and attend the Nottingham CF Centre.
5. Capacity to consent, or to understand the requirements of the study where parent or guardian consent is needed.
6. English-speaking (the panel of questionnaires the investigators will use has so far been validated only in English).
Exclusion Criteria:
EXCLUSIONS TO PARTICIPATION IN ANY PART OF THE STUDY
1. Self-reported diagnosis of an additional gastrointestinal condition e.g. inflammatory bowel disease, coeliac disease or gastrointestinal cancer.
2. Patients from Leeds previously enrolled in the IGLOO-CF Study\* \* Data from the IGLOO-CF Study will form the validation dataset for the latent class analysis in GRAMPUS-CF.
EXCLUSIONS TO PARTICIPATION IN GROUP C (MRI SCANS)
1. Measurement of Forced Expiratory Volume in 1 second (FEV1) of \<40% predicted using Global Lung Initiative criteria, according to clinical records.
2. Contra-indication to MRI scanning, such as embedded metal, pacemaker.
3. Unable to stop medications directly prescribed to alter bowel habit, such as laxatives of anti-diarrhoeals, on the study day.
4. Previous resection of any part of the gastro-intestinal tract apart from appendicectomy or cholecystectomy. Surgical relief of distal intestinal obstruction syndrome or neonatal ileus will be permitted unless clinical records show excision of intestine \>20cm in length.
5. Intestinal stoma
6. Diagnosis of inflammatory bowel disease or coeliac disease confirmed by biopsy
7. Gastrointestinal malignancy
8. Unable to comply with dietary restrictions required for the study
9. Pregnancy - tests are available at the Sir Peter Mansfield Imaging Centre if participants are unsure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT05934656
Study Brief:
Protocol Section:
NCT05934656