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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00164021




Registration number
NCT00164021
Ethics application status
Date submitted
13/09/2005
Date registered
14/09/2005
Date last updated
15/01/2016

Titles & IDs
Public title
The Prevalence and Significance of Gastro-oesophageal Reflux in Cystic Fibrosis Before and After Lung Transplantation
Scientific 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
Secondary ID [1] 0 0
Alfred Hospital $20,000 grant
Secondary ID [2] 0 0
1/01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Cystic fibrosis
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Physiotherapy, exercise, percutaneous gastrostomy feeds
Treatment: Drugs - Anti-reflux pharmacotherapy

Cystic Fibrosis - Patients with cystic fibrosis

Control -


Treatment: Surgery: Physiotherapy, exercise, percutaneous gastrostomy feeds


Treatment: Drugs: Anti-reflux pharmacotherapy


Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
- * Diagnosis of cystic fibrosis

- Medically stable
Minimum age
16 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- * Known oesophageal varices

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Alfred
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Monash University
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00164021
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Brenda M Button, DPhty, PhD
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Brenda M. Button, DPhty, PhD
Address 0 0
Country 0 0
Phone 0 0
9276 2000
Fax 0 0
Email 0 0
b.button@alfred.org.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00164021