Do methods to reduce gastro esophageal reflux (GER) including sleeping posture (elevation of the head of the bad) and use of protein pump inhibitor medications, also reduce pepsin (normally not found in the lung) in the exhaled breath of people with GER.

Can measures to reduce GER, including sleeping posture (elevation of the head of the bed) and use of protein pump inhibitors medication, reduce levels of pepsin in exhaled breath condensate (EBC) of people with GER

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12623000430639

Acronym

PEX-UIP intervention

Enrollment

Registered

2023-04-28

Start date

2023-05-15

Completion date

2023-11-01

Last updated

2023-05-08

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 whether in subjects (people with idiopathic pulmonary fibrosis (IPF) and aged matched controls without lung or gastroesophageal disease) who are found to have pepsin (an enzyme normally found in the stomach and not in the lungs) in the exhaled breath (EBC), simple postural measures and common acid suppression medication can reduce the level of pepsin in the EBC

Interventions

1. Withholding any anti-acid therapy for 7 days except aluminium hydroxide, then: 2. Elevation of the head of the bed during sleeping by the provision of two 15cm high chocks under each side of the head of the bed for 2 days. Subjects will photograph after set up and share with investigators to exclude difficulties and confirm adherence to measure. This will be followed by: 3. Oral omeprazole 20mg twice daily for 7 days. Returned pill bottles / pill count will be used to confirm compliance. A

Study design

Allocation

Non-randomised trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Inclusion Criteria IPF subjects and normal controls demonstrating measurable EBC pepsin.

Exclusion criteria

Any subject without measurable EBC pepsin. Subjects with previous oesophageal or gastric surgery or those unable to withhold acid suppressive medication or with recent respiratory tract infection (2 weeks) will be excluded

Outcome results