Understanding gut symptoms in cystic fibrosis
Gut Research Advancing a Mechanistic and Personalised Understanding of Symptoms in Cystic Fibrosis: The GRAMPUS-CF Strategic Research Centre
This study is trying to understand different gut symptoms in people with cystic fibrosis by using questionnaires and advanced imaging to see how these symptoms relate to inflammation and diet.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | University of Nottingham Academic / other |
| Locations | 1 site (Nottingham, Nottinghamshire) |
| Trial ID | NCT05934656 on ClinicalTrials.gov |
What this trial studies
This observational study aims to characterize gut symptoms in individuals with cystic fibrosis (CF) by identifying distinct symptom phenotypes through questionnaires and advanced imaging techniques. Participants will be grouped based on the severity and type of gastrointestinal symptoms they experience, with data collected over a year to explore the underlying mechanisms. The study will utilize magnetic resonance imaging (MRI) and microbiome analysis to investigate the relationship between gut symptoms, inflammation, and dietary factors. The ultimate goal is to identify potential therapeutic targets and biomarkers for better management of gut symptoms in CF patients.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 6 years and older with a confirmed diagnosis of cystic fibrosis attending designated CF centers.
Not a fit: Patients with additional gastrointestinal conditions such as inflammatory bowel disease or coeliac disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of gastrointestinal symptoms in cystic fibrosis, enhancing patients' quality of life.
How similar studies have performed: While this approach is innovative, previous studies have highlighted the importance of understanding gut symptoms in CF, suggesting potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nottingham, Nottinghamshire
- Nottingham University Hospitals Trust — Nottingham, Nottinghamshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Alan Smyth — University of Nottingham
- Study coordinator: Darren J Sills
- Email: darren.sills1@nottingham.ac.uk
- Phone: 0115 8230612
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.