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

NCT00164021 | Unknown

• 2 other identifiers: 1/01Alfred Hospital $20,000 grant
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

gastroesophageal reflux, gastric reflux, acid reflux, lung transplantation, physiotherapy, anti-reflux medication

Study Arms (2)

Cystic Fibrosis

Patients with cystic fibrosis

Procedure: Physiotherapy, exercise, percutaneous gastrostomy feeds; Drug: Anti-reflux pharmacotherapy

Control

Interventions

Physiotherapy, exercise, percutaneous gastrostomy feeds PROCEDURE

Cystic Fibrosis

Anti-reflux pharmacotherapy DRUG

Cystic Fibrosis

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of the Cystic Fibrosis Unit

You may qualify if:

• \* Diagnosis of cystic fibrosis
• Medically stable

You may not qualify if:

• \* Known oesophageal varices

Sponsors & Collaborators

• Bayside Health: lead
• The Alfred: collaborator
• Monash University: collaborator

Study Sites (1)

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis; Gastroesophageal Reflux

Interventions

Physical Therapy Modalities; Exercise

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brenda M. Button, DPhty, PhD

CONTACT

9276 2000; b.button@alfred.org.au

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 14, 2005
• Study Start: February 1, 2001
• Primary Completion: December 1, 2016
• Last Updated: January 15, 2016

Record last verified: 2016-01

Locations

AU (1)