Gut Research Advancing a Mechanistic and Personalised Understanding of Symptoms in Cystic Fibrosis: The GRAMPUS-CF Strategic Research Centre

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

Although chest infections affect wellbeing and survival in cystic fibrosis (CF), most people with CF also have difficulty digesting food and must take medication for this. In spite of this treatment, two thirds of people with CF miss school or work because of tummy symptoms (pain, bloating and wind). In some cases these symptoms become severe leading to bowel obstruction and hospital admission. Long term, people with CF have a greater risk of bowel cancer. The investigators asked people with CF and health professionals to suggest the most important questions for research. Treatment of gut symptoms was in their top 10 list. Current treatments are often ineffective because the investigators do not fully understand why symptoms occur. GRAMPUS-CF SRC will describe accurately the categories of gut symptoms in CF and find out why they occur. The investigators will do this using magnetic resonance imaging (MRI) scans and tests which give a detailed description of the germs in the bowel or which measure inflammation. The investigators will also study the effects of diet, using a questionnaire. The investigators will link these results together, using advanced statistics to find the factors causing gut symptoms. The investigators will then identify treatments which are likely to be helpful. In future work the investigators will test these in clinical trials.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Healthy Volunteers: f
View:

• 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).

• For participants enrolled in group A via the mobile phone app, self-reported diagnosis will be accepted.

• Adult patients will be aged 16 years and over and attend the Nottingham or Leeds CF Centres.

• Paediatric patients will be aged 6-15 years and attend the Nottingham CF Centre.

• Capacity to consent, or to understand the requirements of the study where parent or guardian consent is needed.

• English-speaking (the panel of questionnaires the investigators will use has so far been validated only in English).

Locations
Other Locations
United Kingdom
Nottingham University Hospitals Trust
RECRUITING
Nottingham
Contact Information
Primary
Darren J Sills
darren.sills1@nottingham.ac.uk
0115 8230612
Backup
GRAMPUS-CF
grampuscf@nottingham.ac.uk
Time Frame
Start Date: 2023-06-26
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 350
Treatments
People with cystic fibrosis
People with confirmed diagnosis aged over six year old
Related Therapeutic Areas
Sponsors
Collaborators: Northumbria University, Vanderbilt University Medical Center, University of Leeds, Motilent, Imperial College London, Cystic Fibrosis Trust, University of Birmingham, Brandenburg Medical School Theodor Fontane, University of Glasgow, Nottingham Trent University, National Institute for Health Research, United Kingdom
Leads: University of Nottingham

This content was sourced from clinicaltrials.gov