Gut-CF
Research type
Research Study
Full title
Validation of a bowel symptom severity score for cystic fibrosis bowel disease (CF-BS)
IRAS ID
220776
Contact name
Peter Whorwell
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust - Wythenshawe Site
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Research Summary
The IBS-SSS is used widely in the gastrointestinal field to assess gut symptom severity in patients with irritable bowel syndrome (IBS). It has been modified to capture additional symptoms in CF bowel disease - referred to as the CF bowel score (CF-BS) and otherwise known as a patient reported outcome measure (PROM). Prior to distribution of the CF-BS, 10 CF patients will be interviewed to ensure that the CF-BS captures all necessary symptoms. All adult CF patients will be eligible provided they meet our entry criteria. The CF-BS PROM will be validated in 100 patients. The remaining CF cohort (n=450) will complete the CF-BS PROM so that we are able to determine the prevalence of symptoms.The patients for validation will be recruited at outpatient appointments where they will be given a patient information sheet and consented prior to taking part in the study. CF-BS will be validated by scores comparing it against a physician, and multi-disciplinary team (MDT) agreed, grading of symptom severity. Reproducibility and ability to capture change will also be assessed. Background information will be collected from the notes and an additional gastro-oesophageal reflux (GOR) symptoms and quality of life questionnaire will be completed.
When the CF-BS has been validated it will be distributed amongst the remaining patients to assess prevalence of CF associated symptoms. This will allow symptomatic patients to be identified. It will also allow for the development of our service, designed around the needs of the CF patients.
Summary of Results
"Cystic fibrosis (CF) is a long-term condition that primarily affects the lungs but can also lead to significant digestive issues. Despite advances in treatments that help people with CF live longer, many still experience gut problems such as abdominal pain, bloating, and reflux. These issues can negatively affect their quality of life but are often overlooked, as CF care is typically focused on lung health rather than gut health.In this study, we assessed the digestive symptoms of 40 people with CF who attended routine clinics. We used questionnaires to measure bowel symptoms, reflux symptoms, and overall quality of life. Doctors also rated the severity of each patient’s gut symptoms without seeing the questionnaire results.
We found that bowel problems were common, with 83% of patients reporting symptoms. Nearly half had moderate to severe bowel symptoms, which were linked to lower quality of life. Interestingly, doctors often underestimated the severity of gut issues compared to the questionnaire results. We also found that reflux symptoms, such as heartburn, were present in over half of the patients and were related to the severity of bowel symptoms. This suggests that gut and reflux problems may share a common cause, such as heightened gut sensitivity.
Our findings highlight the need for greater focus on gut health in CF care and suggest that digestive symptoms should be taken more seriously. Future studies are needed to confirm these findings and explore how to better manage gut problems in people with CF. This could open new opportunities for gastroenterologists to contribute to CF care."
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
18/WM/0064
Date of REC Opinion
9 Jul 2018
REC opinion
Further Information Favourable Opinion