A Validation Study of the Dx-pH Probe in Children for the Detection of Extra-oesophageal Reflux

Summary

Gastro-oesophageal reflux (GORD) and its extraoesophageal manifestations present with a variety of symptoms in both adult and paediatric populations. In children the effects of refluxate above the upper oesophageal sphincter (UES) has been implicated as a contributory factor in the underlying pathological processes of a number of conditions including apnoea, asthma, chronic cough, subglottic stenosis, chronic rhinosinusitis and otitis media. The absence of typical symptoms in addition to the inability to obtain a formal symptom history from a young paediatric population contributes to the difficulty in establishing a diagnosis. At present there are no studies or data directly measuring extraoesophageal reflux and its correlation to oesophageal pH monitoring in children.

The use of twenty-four hour oesophageal pH monitoring is regarded as the established technique for diagnosis of GORD, however this technique has been less reliable for detecting extra-oesophageal reflux. The investigators intend to use the Dx-pH Measurement system, a sensitive and minimally invasive transnasal device, to assess the feasibility and validate its use in a paediatric population.

Conditions

• Gastro-oesophageal Reflux

Interventions

DEVICE

Experiemental diagnostic procedure: Dx-pH measurement system

The Dx-pH Measurement system (Dx-pH; Respiratory Technology Corp., San Diego, CA) is a sensitive and minimally invasive transnasal device for detection of aerosolized extra-oesophageal acid reflux in the posterior oropharynx. The sterile single use Dx-pH catheter will be passed trans-nasally into the same nostril as the same nostril as the other catheter. The internal pH value of the oesophagus is then continuously measured and recorded onto a small ambulatory device. The 2 catheters are connected to the ambulatory recording devices and recording commences. The duration of the investigation is 24 hours.

OTHER

Peptest assay

A saliva sample of 0.5-1 ml will then be taken for pepsin assay (Peptest). The saliva sample will be drawn into a micro-centrifuge tube (0.5ml) and centrifuged. 80 microlitres is taken from the supernatant layer, vortex mixed, then applied to the assay test strip. The result is obtained after 15 minutes. The saliva sample will then be securely disposed.

OTHER

GORD symptom questionnaire

A validated 7 domain GORD symptom questionnaire (GSQ-YC) to quantify the GORD related symptoms their child suffers with is to be completed prior to any intervention.

Sponsors & Collaborators

• Manchester University NHS Foundation Trust

  lead OTHER_GOV

Principal Investigators

• Iain A Bruce · Royal Manchester Children's Hospital

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

1 Year

Max Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-03-22

Primary Completion

2017-04-28

Completion

2017-04-28

Countries

• United Kingdom

Study Locations