Condition category
Digestive System
Date applied
16/06/2015
Date assigned
30/06/2015
Last edited
20/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

www.uhsm.nhs.uk

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

Publication citations

Additional files

Editorial Notes