Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00164021
Status:
UNKNOWN
Last Update Posted:
2016-01-15
First Post:
2005-09-13
Brief Title:
The Prevalence and Significance of Gastro-oesophageal Reflux in Cystic Fibrosis Before and After Lung Transplantation
Sponsor:
Bayside Health
Organization:
Bayside Health
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2016-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Gastro-oesophageal reflux GOR has been found to be prevalent in children with cystic fibrosis CFand 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
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 refluxGOR 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 FEV1FVC 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 patients symptom scores
3 Dual-channel 24hour oesophageal pH monitoring will be undertaken using a digitrapper Medtronic Swedenand 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 oesophagusThe 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 exerciseThe 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
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 FEV1FVC 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 patients symptom scores
3 Dual-channel 24hour oesophageal pH monitoring will be undertaken using a digitrapper Medtronic Swedenand 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 oesophagusThe 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 exerciseThe 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Alfred Hospital 20000 grant | None | None | None |