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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Bayside Health.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
The Alfred
Monash University
Information provided by (Responsible Party):
Bayside Health
ClinicalTrials.gov Identifier:
NCT00164021
First received: September 13, 2005
Last updated: December 3, 2013
Last verified: September 2005
  Purpose

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 Intervention
Cystic Fibrosis
Procedure: Physiotherapy, exercise, percutaneous gastrostomy feeds
Drug: Anti-reflux pharmacotherapy

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bayside Health:

Estimated Enrollment: 180
Study Start Date: February 2001
Groups/Cohorts Assigned Interventions
Cystic Fibrosis Procedure: Physiotherapy, exercise, percutaneous gastrostomy feeds Drug: Anti-reflux pharmacotherapy
Control

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
  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients of the Cystic Fibrosis Unit

Criteria

Inclusion Criteria:

  • * Diagnosis of cystic fibrosis

    • Medically stable

Exclusion Criteria:

  • * Known oesophageal varices
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00164021

Contacts
Contact: Brenda M. Button, DPhty, PhD 9276 2000 ext 3450 b.button@alfred.org.au

Locations
Australia, Victoria
The Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Brenda M Button, DPhty, PhD    9276 2000 ext 3450    b.button@alfred.org.au   
Contact: John W Wilson, MBBS, PhD    9276 2000 ext 3600    john.wilson@med.monash.edu.au   
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
Investigators
Principal Investigator: Brenda M Button, DPhty, PhD The Alfred Hospital, Melbourne
Principal Investigator: Susannah King The Alfred Hospital, Melbourne
Principal Investigator: Colleen Ash The Alfred Hospital, Melbourne
Principal Investigator: John W Wilson, MBBS, PhD The Alfred Hospital, Melbourne
Principal Investigator: Greg Snell, MBBS The Alfred Hospital, Melbourne
Principal Investigator: Stuart Roberts, MBBS The Alfred
  More Information

No publications provided

Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT00164021     History of Changes
Other Study ID Numbers: 1/01, Alfred Hospital $20,000 grant
Study First Received: September 13, 2005
Last Updated: December 3, 2013
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Bayside Health:
gastroesophageal reflux, gastric reflux, acid reflux, lung transplantation, physiotherapy, anti-reflux medication

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Gastroesophageal Reflux
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on September 16, 2014