GOR in CF
Research type
Research Study
Full title
Gastro-oesophageal reflux in patients with cystic fibrosis and it's effect on lung function
IRAS ID
177609
Contact name
A Jones
Contact email
Sponsor organisation
University Hospital of South Manchester NHS Foundation Trust
ISRCTN Number
ISRCTN59493612
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
Gastro-oesophageal reflux (GOR) is common in patients with cystic fibrosis (CF). Although symptoms such as heartburn and acid taste in the mouth can occur, often it is asymptomatic. Studies have suggested a link between worsening lung function and amount of GOR. A potential mechanism is by stomach contents travelling into the lungs (extra-oesophageal reflux), causing inflammation and altering the usual organisms which inhabit the airways. If proven there may be potential role for new medical therapies (tablets) and / or surgical strategies.
My aim is to investigate if GOR affects lung function. We will also look at sputum samples (phlegm) to assess microbiology and presence of makers of reflux aspiration. These are substances that are found in the gastrointestinal tract that if detected in sputum supports presence of stomach contents in the lungs. In addition factors that may influence GOR, such as antacids tablets and enteral (via a tube into the stomach) feeding, will be evaluated.
I intend to measure GOR using special probes to measure function of the oesphagus, pH (acidity) and presence of gastric contents within the gullet. The participants will provide measures of lung function, clinical details, throat swabs, blood and sputum samples as well as complete symptom questionnaires.
To look further at how GOR may affect lung function we will be collecting samples from healthy volunteers to compare against the Cystic Fibrosis Patients. It will be run over one site. We aim to enrol one hundred patients and obtain 15 sputum samples and throat swabs from healthy volunteers. The patient will have to attend two additional clinic appointments. Sputum samples will be stored in secure freezers to allow tests to be conducted in the future.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
15/NW/0655
Date of REC Opinion
13 Oct 2015
REC opinion
Further Information Favourable Opinion