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Gastro-oesphageal reflux in patients with cystic fibrosis and its effect on lung function.

Gastro-oesphageal reflux in patients with cystic fibrosis and its effect on lung function: an observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN59493612
Enrollment
100
Registered
2015-06-30
Start date
2015-09-01
Completion date
Unknown
Last updated
2021-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastro-oesophageal reflux in cystic fibrosis Digestive System Gastro-oesophageal reflux disease (GORD)

Interventions

Gastro-oesphophageal reflux will be measured using 24 hour combined pH and multichannel intraluminal impedence (pH-MII) in a cohort of cystic fibrosis patients recruited from the outpatient clinic. Re

Sponsors

University Hospital South Manchester
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026