Understanding Gut Symptoms in People With Cystic Fibrosis

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.

Conditions

• Cystic Fibrosis
• Gastrointestinal Dysfunction

Interventions

OTHER

Latent class analysis

The investigators will conduct a longitudinal study comprising nested groups A to C of the study population, with progressively more detailed mechanistic investigations. No control group. Group A will complete a CF-specific measure of gut symptoms (CFAbd-Score), a generic constipation score (PAC-SYM) and 24 hour dietary recall (Intake24). Group B will have stool and blood for microbiome, inflammatory mediators and faecal fat. Group C will have gut MRI and exploratory studies of inflammation.

Sponsors & Collaborators

• Cystic Fibrosis Trust

  collaborator OTHER

• Motilent

  collaborator UNKNOWN

• Nottingham Trent University

  collaborator OTHER

• Vanderbilt University Medical Center

  collaborator OTHER

• University of Leeds

  collaborator OTHER

• Brandenburg Medical School Theodor Fontane

  collaborator OTHER

• University of Glasgow

  collaborator OTHER

• National Institute for Health Research, United Kingdom

  collaborator OTHER_GOV

• University of Birmingham

  collaborator OTHER

• Northumbria University

  collaborator OTHER

• Imperial College London

  collaborator OTHER

• University of Nottingham

  lead OTHER

Principal Investigators

• Alan Smyth · University of Nottingham

Eligibility

Min Age

6 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-26

Primary Completion

2025-09-30

Completion

2026-03-31

Countries

• United Kingdom

Study Locations