Understanding Gut Symptoms in People With Cystic Fibrosis

Launched by UNIVERSITY OF NOTTINGHAM · Jun 28, 2023

Keywords

ClinConnect Summary

This clinical trial, called "Understanding Gut Symptoms in People With Cystic Fibrosis," is focused on exploring the digestive problems that many individuals with cystic fibrosis (CF) experience. While CF is often known for causing lung infections, a significant number of people also have issues like stomach pain, bloating, and gas, which can lead to missed school or work and sometimes even require hospital visits. The researchers want to better understand these gut symptoms and their causes. They will use advanced imaging techniques and tests to gather information about the gut and the germs that live there, as well as how diet might impact symptoms. This information will help them identify potential treatments to improve the quality of life for those affected by CF.

To participate in this study, individuals must be diagnosed with cystic fibrosis and be between the ages of 6 to 15 (children) or 16 and older (adults). They should be attending specific CF centers in Nottingham or Leeds and be able to communicate in English. Participants will undergo various tests, including MRI scans, and complete questionnaires about their diet and gut health. It's important to note that those with certain other gastrointestinal conditions or specific medical histories may not be eligible. This research aims to provide a clearer understanding of gut issues in CF, paving the way for better treatments in the future.

Gender

ALL

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.