Not Yet RecruitingPhase 4ACTRN12623000430639

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

Sponsor

Mater Misericordiae LTD

Enrollment

20 participants

Start Date

May 15, 2023

Study Type

Interventional

Conditions

Gastro oesophageal reflux (GER)Idiopathic Pulmonary Fibrosis (IPF)

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

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

IPF subjects and normal controls demonstrating measurable EBC pepsin.

Exclusion Criteria1

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

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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 h

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 washout period of one week will occur between interventions