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Can pepsin, a digestive enzyme normally found in the gastro intestinal tract, be found in the exhaled breath of people with idiopathic pulmonary fibrosis (IPF) and is nitric oxide present in excess amounts. How do these results compare with normal individuals and are results repeatable.

Exhaled Breath Condensate (EBC) pepsin and nitric oxide (NO) levels in Idiopathic Pulmonary Fibrosis compared with healthy controls

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12623000367640
Acronym
PEX-UIP
Enrollment
40
Registered
2023-04-13
Start date
2023-05-15
Completion date
2023-11-01
Last updated
2023-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will investigate the levels of pepsin (an enzyme normally found in the stomach and not in the lungs) in the exhaled breath (EBC) of patients with idiopathic pulmonary fibrosis (IPF) and compare them to levels recorded in healthy, matched adults. This information will help the understanding of whether pepsin (or other stomach contents) may contribute to the development of IPF

Interventions

IPF subjects and age matched individuals (without respiratory disease or symptoms of gastroesophageal reflux (GER)) will perform an exhaled breath condensate manoeuvre on 3 consecutive weekdays from which measurements of pepsin and nitric oxide will be made. • EBC collection: Collection will occur using a proprietary device including a saliva trap (R-tubes, Respiratory Research, Austin Texas) using established techniques. • Patients will be fasting for 3hr for food and 2h for water; avoid al

IPF subjects and age matched individuals (without respiratory disease or symptoms of gastroesophageal reflux (GER)) will perform an exhaled breath condensate manoeuvre on 3 consecutive weekdays from which measurements of pepsin and nitric oxide will be made. • EBC collection: Collection will occur using a proprietary device including a saliva trap (R-tubes, Respiratory Research, Austin Texas) using established techniques. • Patients will be fasting for 3hr for food and 2h for water; avoid alcoholic drinks, coffee and other food or beverages containing caffeine (cola, tea, cocoa) for at least 3 h before the examination. They should also abstain from foods containing nitrates (lettuce, spinach, cabbage, sausages) and high-fat foods for at least 12h before the examination. • Collection will take place over 10 minutes with the subjects sitting comfortably upright and exhaling through the cold R-tubes (chilled to -20degC) • Collection time will be standardised to be between 9 and 10 am

Sponsors

Mater Hospital Brisbane
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Inclusion Criteria IPF subjects a. American Thoracic Society / European Respiratory Society criteria for diagnosis definite or probable idiopathic pulmonary fibrosis (IPF) b. Aged greater than or equal to 18 years with no upper limit c. Capable of providing written informed consent Healthy subjects Age matched without pulmonary disease or know gastro oesophageal reflux

Exclusion criteria

Exclusion criteria IPF Subjects a. Previous esophageal or gastric surgery b. Unable to discontinue anti acid medication for 7 days except aluminium hydroxide c. Any respiratory tract infection (including upper respiratory tract infection) within 4 weeks of recruitment d. Pregnant women e. Unable to breathe into the EBC device Age matched volunteers Active pulmonary disease or gastro oesophageal reflux Plus as per IPFsubjects

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026