Gastro-oesophageal reflux in cystic fibrosis Digestive System Gastro-oesophageal reflux disease (GORD)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Confirmed diagnosis of cystic fibrosis 2. Aged over 18 3. Provision of signed, written and dated informed consent, prior to any study specific procedures
Exclusion criteria
Exclusion criteria: 1. An acute exacerbation within two weeks of completing oral or intravenous antibiotics 2. Pregnant 3. Post-lung transplant 4. Fundoplication 5. Known infection with burkholderia cepacia complex organisms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the characteristics of GOR and its correlation to the severity of respiratory disease in patients with cystic fibrosis. Collected at either the first or second visit. Evaluation of the notes will provide any additional data. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluate the relationship between GOR and airway microbiology 2. Evaluate the correlation between proximal GOR and sputum markers of extra-oesophageal reflux 3. Evaluate proposed sputum microbiology and markers of aspiration in CF patients against healthy controls 4. Evaluate the impact on GOR characteristics of those receiving Ivacaftor, PPI or enteral feeding 5. Evaluate the impact on GOR characteristics of patients characteristics including genotype, weight and sex Collected at either the first or second visit. Evaluation of the notes will provide any additional data. | — |
Countries
United Kingdom