Comparing levels of pepsin in saliva with 24-hour probe monitoring in patients clinically diagnosed with Laryngopharyngeal Reflux (LPR)

Comparing Salivary Pepsin Measurement to 24 hour Dual Probe Oropharyngeal/Oesophageal pH/Impedance monitoring in patients with a clinical diagnosis of Laryngopharyngeal Reflux: a prospective study

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618000251224

Enrollment

Registered

2018-02-16

Start date

2018-08-05

Completion date

2020-02-10

Last updated

2021-06-21

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

Conditions

None listed

Brief summary

Aim: To demonstrate the usefulness of two tests for laryngopharyngeal reflux (pH/Impedance and Oral Pepsin ELISA) Participants: 50 adults (>18 years) with a clinical diagnosis of laryngopharyngeal reflux (LPR) presenting to ENT/laryngology clinic. Method: Informed consent will be gained from participants, who will be asked to first complete two forms related to their experience of reflux (Belafsky Reflux Symptom Index (RSI)& Vocal Tract Discomfort Scale). Participants will then have a 24hour dual pH/Impedance probe placed in clinic, confirmed by either manometry (preferred) or direct visualised pullback (DVP) method depending on final departmental budgeting. During this 24 hr period, up to 5 salivary samples will also be collected: 1x upon waking and standing but before breakfast and teethbrushing, 1x 60minutes after lunch and 1x 60 minutes after dinner. The fourth and fifth samples may be collected following symptoms being experienced by the patient. After 24 hours the probe will be removed and the salivary samples will be returned to the clinic, refrigerated at 4 degrees and analysed within 2 days. We expect to see increased diagnostic value of combing the results of these two tests.

Interventions

The patient will be given 5 sputum collection jars with a special reagant. During the same 24 hour period of the 24-hour dual pH/Impedance probe being in situ (after being placed transnasally in clinic), up to 5 of the patient's sputum samples will be collected in these jars. 1st sample - after waking and standing up but before brushing teeth or eating 2nd sample - 60 minutes after lunch 3rd sample - 60 minutes after dinner +/- 4th/5th sample - immediately after experiencing one of the key symptoms. * - N.B. - In patients with a diagnosis of laryngopharyngeal reflux, clinicians will elucidate the 3 key symptoms that the patient experiences as a result of their LPR. Patients will be instructed on how to collect these samples and to keep them refrigerated. These will also be returned to the clinic where it will be kept refrigerated until analysis by the research team.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Diagnosis

Masking

Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

50 consenting adult patients (>18 years) presenting to a tertiary ENT/Laryngology Clinic with laryngopharyngeal reflux (LPR)

Exclusion criteria

- People who are unable or unwilling to consent - People who are unable to complete the pre-intervention questionnaire (Belafsky Reflux Symptom Index (RSI) and Vocal Tract Discomfort Scale).

Outcome results