Plain English Summary
Background and study aims
Gastro-oesophageal reflux disease (GORD) is a condition where acid from the stomach leaks out of the stomach and up into the oesophagus (gullet). It is common in patients with cystic fibrosis (CF), a genetic condition where the lungs and digestive system become clogged with mucus. Although symptoms such as heartburn and acid taste in the mouth can occur, often there are no symptoms. Studies have suggested a link between a worsening lung function and the amount of GORD. A potential mechanism is by the stomach content travelling into the lungs causing inflammation and altering the usual organisms that are present. If that is the case, there may be opportunities for new drugs and/or surgical procedures. The aim of this observational study is to investigate if GORD affects the lung function.
Who can participate?
Adult patients from the Manchester Adult Cystic Fibrosis Centre outpatient clinic diagnosed with cystic fibrosis. Healthy volunteers will also participate, for comparison purposes.
What does the study involve?
It will involve looking at sputum samples (phlegm) to assess microbiology and presence of markers of reflux aspiration. These are substances that are found in the gastrointestinal tract and that, if detected in sputum, supports presence of stomach contents in the lungs. In addition factors that may influence GORD, such as antacids tablets and enteral feeding (via a tube into the stomach) will be evaluated. GORD will be measured by using special probes that assess the function of the oesophagus, pH (acidity) and presence of gastric contents within the gullet. The participants will provide measures of lung function, clinical details, blood and sputum samples as well as complete symptom questionnaires. They 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. Travel expenses will be paid for.
What are the possible benefits and risks of participating?
We envisage no significant risks. Participants will be provided with an accurate assessment of their gastro-oesophageal reflux, which may be used to improve their clinical care.
Where is the study run from?
University Hospitals South Manchester (UK)
When is the study starting and how long is it expected to run for?
August 2015 to August 2018.
Who is funding the study?
Manchester Adult Cystic Fibrosis Centre (UK)
Who is the main contact?
Dr Robert Lord
Trial website
Contact information
Type
Scientific
Primary contact
Dr Robert Lord
ORCID ID
http://orcid.org/0000-0001-9008-2502
Contact details
University Hospital South Manchester
Southmoor Road
Manchester
M23 9LT
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Gastro-oesphageal reflux in patients with cystic fibrosis and its effect on lung function: an observational study
Acronym
Study hypothesis
In patients with cystic fibrosis, gastro-oesophageal reflux (GOR) directly impacts on respiratory disease. This is a consequence of micro-aspiration of gastric contents into the airways.We postulate that this is a consequence of increased airway inflammation, in part due to modification of the airway microbiome.
Ethics approval
Research Ethics Committee Greater Manchester South, 13/10/2015, ref: 15/NW/0655
Study design
Single-centre longitudinal observational study
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Gastro-oesophageal reflux in cystic fibrosis
Intervention
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. Relevant medical history and clinical data, measures of lung function upon enrollment, blood and sputum samples will be obtained. Prevalence of GORD will be compared to severity of lung disease. The sputum samples will be analysed for both culture and non-culture dependent microbiology as well as for presence of biomarkers of extra-oesphageal GORD. We intend to enroll healthy volunteers for induced sputum to allow comparision of microbiology and biomarkers of estra-oesopahageal GORD.
Intervention type
Other
Phase
Drug names
Primary outcome measures
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 outcome measures
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.
Overall trial start date
01/08/2015
Overall trial end date
01/08/2018
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant 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
Recruitment start date
01/09/2015
Recruitment end date
01/06/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospitals South Manchester
Southmoor Road
Manchester
M21 9AX
United Kingdom
Sponsor information
Organisation
University Hospital South Manchester
Sponsor details
Southmoor Road
Manchester
M23 9LT
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Manchester Adult Cystic Fibrosis Centre
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We will report the findings through conferences and journals. They will also be published in a PhD thesis.
Intention to publish date
01/11/2018
Participant level data
Available on request
Results - basic reporting
Publication summary