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The Prevalence and Significance of Gastro-oesophageal Reflux in Cystic Fibrosis Before and After Lung Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00164021
Recruitment Status : Unknown
Verified January 2016 by Bayside Health.
Recruitment status was:  Recruiting
First Posted : September 14, 2005
Last Update Posted : January 15, 2016
The Alfred
Monash University
Information provided by (Responsible Party):
Bayside Health

Brief Summary:
Gastro-oesophageal reflux (GOR) has been found to be prevalent in children with cystic fibrosis (CF)and may further worsen lung damage via reflex bronchospasm or pulmonary aspiration. Chest physiotherapy may result in increased episodes of GOR as demonstrated in children. Lung transplantation may worsen pre-existing GOR. This study will determine the prevalence, severity and significance of symptomatic and silent GOR in adults with CF before and after lung transplant using 24hr oesophageal pH monitoring, a valid symptom questionnaire, quality of life questionnaires and gastric emptying studies. This study will identify the extent of GOR in a large adult CF population and the impact on lung function and quality of life together with the effects of medical and physiotherapy treatment on gastro-oesophageal function.

Condition or disease Intervention/treatment
Cystic Fibrosis Procedure: Physiotherapy, exercise, percutaneous gastrostomy feeds Drug: Anti-reflux pharmacotherapy

Detailed Description:

A factorial longitudinal study will be undertaken in adults with cystic fibrosis. Results will be compared with age matched healthy controls. It is not deemed appropriate to randomise patients with gastro-oesophageal reflux(GOR) to a treatment versus no treatment group as immediate treatment for GOR once diagnosed is regarded as obligatory.

Subjects: 180 adults with CF will be recruited from the Adult Cystic Fibrosis Unit at the Alfred Hospital to participate in the study. The ambulatory studies will be undertaken during baseline state in the outpatient setting. Fifteen age matched control subjects will be recruited from the general population.

Subjects who give their consent for participation in the study will undertake the following outcome measures:

  1. Demographic data including age, gender, BMI, prescribed medication at the time of the study, lung function tests including FEV1, FVC, FEV1/FVC ratio and MMEF, genotype, pH of saliva and sputum.
  2. Structured symptom questionnaire using a reliable valid measure developed by Carlsson et al 1998 will be used to assess patient's symptom scores.
  3. Dual-channel 24hour oesophageal pH monitoring will be undertaken using a digitrapper (Medtronic, Sweden)and dual antimony tipped probe (Synectics, Sweden). Following calibration of the probes the distal antimony tip is positioned 5cm above the upper border of the lower oesophageal sphincter and the proximal probe 15 cm above the distal probe in the upper oesophagus.The patient will be instructed in using the three event buttons on the digitrapper recording start and finish time of meals, upright versus supine positioning and reflux episodes. The subject will be provided with a detailed 24hr 'Activity Diary' to record all meals (including percutaneous gastrostomy feeds), positions and activities including usual chest physiotherapy and physical exercise.The recorded pH information is downloaded into a computer program for analysis. The following indices will be measured in the distal and proximal oesophagus:

    • Number of reflux episodes
    • Fraction of reflux time
    • Number of reflux episodes with duration longer than 5 minutes
    • Duration of longest episodes in minutes
    • DeMeester score (an overall weighted score of gastro-oesophageal function).
  4. Quality of life questionnaires: SF36, Quittner CF Questionnaire (CFQ), Dietary and Bowel Symptom Questionnaires.
  5. Chest radiographs

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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Prevalence and Significance of Gastro-oesophageal Reflux in Adults With Cystic Fibrosis Before and After Lung Transplantation, Together With the Effects of Physiotherapy Airway Clearance Techniques on Gastro-oesophageal Function
Study Start Date : February 2001
Estimated Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Cystic Fibrosis
Patients with cystic fibrosis
Procedure: Physiotherapy, exercise, percutaneous gastrostomy feeds
Drug: Anti-reflux pharmacotherapy

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients of the Cystic Fibrosis Unit

Inclusion Criteria:

  • * Diagnosis of cystic fibrosis

    • Medically stable

Exclusion Criteria:

  • * Known oesophageal varices

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00164021

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Contact: Brenda M. Button, DPhty, PhD 9276 2000 ext 3450

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Australia, Victoria
The Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Brenda M Button, DPhty, PhD    9276 2000 ext 3450   
Contact: John W Wilson, MBBS, PhD    9276 2000 ext 3600   
Principal Investigator: Brenda M Button, DPhty,PhD         
Sub-Investigator: Susannah King         
Sub-Investigator: Colleen Ash         
Sub-Investigator: John W Wilson, MBBS, PhD         
Sub-Investigator: Greg Snell, MBBS         
Sub-Investigator: Stuart Roberts, MBBS         
Sponsors and Collaborators
Bayside Health
The Alfred
Monash University
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Principal Investigator: Brenda M Button, DPhty, PhD The Alfred
Principal Investigator: Susannah King The Alfred
Principal Investigator: Colleen Ash The Alfred
Principal Investigator: John W Wilson, MBBS, PhD The Alfred
Principal Investigator: Greg Snell, MBBS The Alfred
Principal Investigator: Stuart Roberts, MBBS The Alfred
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Responsible Party: Bayside Health Identifier: NCT00164021    
Other Study ID Numbers: 1/01
Alfred Hospital $20,000 grant
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: January 15, 2016
Last Verified: January 2016
Keywords provided by Bayside Health:
gastroesophageal reflux, gastric reflux, acid reflux, lung transplantation, physiotherapy, anti-reflux medication
Additional relevant MeSH terms:
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Cystic Fibrosis
Gastroesophageal Reflux
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases