Gastro-oesophageal RefluxNCT02457429
A Validation Study of the Dx-pH Probe in Children for the Detection of Extra-oesophageal Reflux
A study testing Experiemental diagnostic procedure: Dx-pH measurement system, Peptest assay and GORD symptom questionnaire in people with Gastro-oesophageal Reflux, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Gastro-oesophageal Reflux
- What is being tested?
- Experiemental diagnostic procedure: Dx-pH measurement system, Peptest assay and GORD symptom questionnaire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Mar 2013to 28 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children between the age of 1 year old and 16 years old consecutively referred for outpatient 24 hour oesophageal pH / impedance monitoring will be invited to participate in the study. This is regardless of the underlying diagnosis, aetiology and manifestation of symptoms.
Who cannot join
- Children under the age of 1 year old. Children under 1 year old will be excluded due to the technical difficulty of placing both the pH / impedance monitoring probe and the Dx-pH probe into the same nostril. Firstly, this is due to the size restriction of placing 2 probes into one nostril. Secondly, the non-pathologic high incidence of regurgitation and positing in below the age of 1 will make data difficult to interpret.
- Children with an nasogastric feeding tube in situ will be excluded. Firstly due to the difficulty in placing and securing the nasogastric, oesophageal pH and Dx-pH probe (3 tubes / probes) through the nostrils, with resultant bilateral nasal obstruction. Secondly, the nasogastric tube causes increased iatrogenic reflux within the pharynx, making data more difficult to interpret and creating artificial reflux events.
- Children with cleft palate prior to surgical repair will be excluded as the Dx-pH probe will be difficult to locate in the oropharynx and may displace into the oral cavity.
- Children requiring pH monitoring as inpatients during an acute medical admission. Children will be excluded from the study if their condition has necessitated an acute hospital admission, therefore participation in the study will not affect other ongoing investigations, treatment or their acute condition.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Manchester Children's Hospital
Manchester, M13 9WL
About this study
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.
Read the detailed description
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. As a result there is no baseline data for a paediatric population and subsequently no measureable definition of a significant extraoesophageal reflux event. There is a poor correlation between reflux events measured with an oesophageal probe and extra-oesophageal symptoms of reflux. Studies have demonstrated that 51% of patients without pharyngeal reflux had abnormal distal oesophageal pH studies.
This is secondary to both technical concerns regarding the ability of such probes in detecting aerosolized and vapour forms of reflux in the pharynx and due to the inadequacy of the definition of a significant reflux event above the upper oesophageal sphincter. Moving cephaled (upwards) within the upper aerodigestive tract will result in shorter, higher pH events that may not be recognised using traditional oesophageal analysis, which define a pH<4 as defining a significant oesophageal reflux event.
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 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 investigators intend to use the Dx-pH measurement system and the Peptest salivary pepsin assay (RBiomed, UK) in children already undergoing oesophageal pH studies. The investigators aim to assess the feasibility of these systems in a paediatric population,to provide baseline data and to validate its use in measuring extra-oesophageal reflux events in children. These results will be correlated against symptom questionnaire scores and the results of the 24 hour oesophageal pH study results.
The investigators' results will guide further interventional studies in this area, with the eventual aim of improving diagnosis and guided treatment for the extra-oesophageal manifestations of GORD
- Conditions
- Gastro-oesophageal Reflux
- Being tested
- Experiemental diagnostic procedure: Dx-pH measurement system, Peptest assay, GORD symptom questionnaire
- Keywords
- Gastro-oesophageal reflux, Children, Dx-pH Pharyngeal probe, GORD, Trans-nasal catheter
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experiemental diagnostic procedure: Dx-pH measurement systemDevice
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.
Peptest assayOther
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.
GORD symptom questionnaireOther
Also called (GSQ-YC)
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.
| Study group | Role | What they receive |
|---|---|---|
| Routine oesophageal pH monitoring | Other | Routine oesophageal pH investigation involves the trans-nasal placement of a microelectrode into the distal oesophagus as per hospital protocol. Examining the oropharynx and confirming visualisation of the red LED at the catheter tip in the correct position just below the soft palate will confirm its position in the oropharynx. 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. Receives: Device: Experiemental diagnostic procedure: Dx-pH measurement system; Other: Peptest assay; Other: GORD symptom questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
pH readings from Dx-pH measurement system
Baseline pH readings from Dx-pH measurement system. Measuring reflux events at pH <4, <4.5, <5.0 and <6.0.
Measured: 24 hours
pH readings from Dx-pH measurement system
Baseline pH readings from Dx-pH measurement system. Measuring events per hour at pH <4, <4.5, <5.0 and <6.0
Measured: 24 hours
pH readings from Dx-pH measurement system
Baseline pH readings from Dx-pH measurement system. Measuring total reflux time at pH <4, <4.5, <5.0 and <6.0.
Measured: 24 hours
pH readings from Dx-pH measurement system
Baseline pH readings from Dx-pH measurement system. Measuring percentage reflux time at pH <4, <4.5, <5.0 and <6.0.
Measured: 24 hours
pH readings from Dx-pH measurement system
Baseline pH readings from Dx-pH measurement system. Measuring the longest reflux period at pH <4, <4.5, <5.0 and <6.0.
Measured: 24 hours
Secondary outcomes (7)
Conventional oesophageal pH / impedance readings
Number of reflux events at pH <4, <4.5, <5.0, <6.0 will be measured.
Measured: 24 hours
Conventional oesophageal pH / impedance readings
Number of events per hour at pH <4, <4.5, <5.0 and <6.0 will be measured.
Measured: 24 hours
Conventional oesophageal pH / impedance readings
Total reflux time at pH <4, <4.5, <5.0, <6.0 will be measured.
Measured: 24 hours
Conventional oesophageal pH / impedance readings
Percentage reflux time at pH <4, <4.5, <5.0, <6.0 will be measured.
Measured: 24 hours
Conventional oesophageal pH / impedance readings
The longest reflux period. at pH <4, <4.5, <5.0, <6.0 will be measured.
Measured: 24 hours
GORD related symptoms (GSQ-YC)
A validated 7 domain GORD symptom questionnaire (GSQ-YC) to quantify the GORD related symptoms their child suffers with.
Measured: At time of measurement
Pepsin (Peptest)
A saliva sample of 0.5-1ml will then be taken for pepsin assay (Peptest). The saliva sample will be drawn into a microcentrifuge tube (0.5ml) and centrifuged. 80 microlitres is taken from the supernatant layer, vortex mixed, then applied to the assay test strip.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study start22 Mar 2013
- Primary completion28 Apr 2017
- Study completion28 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-oesophageal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Iain A Bruce, Principal investigator, Royal Manchester Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457429
- Sponsor's protocol ID
- R01843
- Status last verified
- Jan 2019
- First submitted
- 31 Mar 2015
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Validation Study of the Dx-pH Probe in Children for the Detection of Extra-oesophageal Reflux
- ClinicalTrials.gov ID
- NCT02457429
- Acronym / sponsor ID
- R01843
- Conditions
- Gastro-oesophageal Reflux
- Keywords
- Gastro-oesophageal reflux, Children, Dx-pH Pharyngeal probe, GORD, Trans-nasal catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- 22 Mar 2013 (actual)
- Primary completion
- 28 Apr 2017 (actual)
- Study completion
- 28 Apr 2017 (actual)
- First posted
- 29 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. As a result there is no baseline data for a paediatric population and subsequently no measureable definition of a significant extraoesophageal reflux event. There is a poor correlation between reflux events measured with an oesophageal probe and extra-oesophageal symptoms of reflux. Studies have demonstrated that 51% of patients without pharyngeal reflux had abnormal distal oesophageal pH studies.
This is secondary to both technical concerns regarding the ability of such probes in detecting aerosolized and vapour forms of reflux in the pharynx and due to the inadequacy of the definition of a significant reflux event above the upper oesophageal sphincter. Moving cephaled (upwards) within the upper aerodigestive tract will result in shorter, higher pH events that may not be recognised using traditional oesophageal analysis, which define a pH<4 as defining a significant oesophageal reflux event.
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 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 investigators intend to use the Dx-pH measurement system and the Peptest salivary pepsin assay (RBiomed, UK) in children already undergoing oesophageal pH studies. The investigators aim to assess the feasibility of these systems in a paediatric population,to provide baseline data and to validate its use in measuring extra-oesophageal reflux events in children. These results will be correlated against symptom questionnaire scores and the results of the 24 hour oesophageal pH study results.
The investigators' results will guide further interventional studies in this area, with the eventual aim of improving diagnosis and guided treatment for the extra-oesophageal manifestations of GORD
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Routine oesophageal pH monitoring | Other | Device: Experiemental diagnostic procedure: Dx-pH measurement system, Other: Peptest assay, Other: GORD symptom questionnaireRoutine oesophageal pH investigation involves the trans-nasal placement of a microelectrode into the distal oesophagus as per hospital protocol. Examining the oropharynx and confirming visualisation of the red LED at the catheter tip in the correct position just below the soft palate will confirm its position in the oropharynx. 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. |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children between the age of 1 year old and 16 years old consecutively referred for outpatient 24 hour oesophageal pH / impedance monitoring will be invited to participate in the study. This is regardless of the underlying diagnosis, aetiology and manifestation of symptoms.
Key exclusion criteria (4 listed)
- Children under the age of 1 year old. Children under 1 year old will be excluded due to the technical difficulty of placing both the pH / impedance monitoring probe and the Dx-pH probe into the same nostril. Firstly, this is due to the size restriction of placing 2 probes into one nostril. Secondly, the non-pathologic high incidence of regurgitation and positing in below the age of 1 will make data difficult to interpret.
- Children with an nasogastric feeding tube in situ will be excluded. Firstly due to the difficulty in placing and securing the nasogastric, oesophageal pH and Dx-pH probe (3 tubes / probes) through the nostrils, with resultant bilateral nasal obstruction. Secondly, the nasogastric tube causes increased iatrogenic reflux within the pharynx, making data more difficult to interpret and creating artificial reflux events.
- Children with cleft palate prior to surgical repair will be excluded as the Dx-pH probe will be difficult to locate in the oropharynx and may displace into the oral cavity.
- Children requiring pH monitoring as inpatients during an acute medical admission. Children will be excluded from the study if their condition has necessitated an acute hospital admission, therefore participation in the study will not affect other ongoing investigations, treatment or their acute condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experiemental diagnostic procedure: Dx-pH measurement systemThe 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. | Device | Routine oesophageal pH monitoring |
| Peptest assayA 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 | Routine oesophageal pH monitoring |
| GORD symptom questionnaireAlso: (GSQ-YC)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. | Other | Routine oesophageal pH monitoring |
Primary outcome
pH readings from Dx-pH measurement system
Time frame: 24 hours
Baseline pH readings from Dx-pH measurement system. Measuring reflux events at pH <4, <4.5, <5.0 and <6.0.
pH readings from Dx-pH measurement system
Time frame: 24 hours
Baseline pH readings from Dx-pH measurement system. Measuring events per hour at pH <4, <4.5, <5.0 and <6.0
pH readings from Dx-pH measurement system
Time frame: 24 hours
Baseline pH readings from Dx-pH measurement system. Measuring total reflux time at pH <4, <4.5, <5.0 and <6.0.
pH readings from Dx-pH measurement system
Time frame: 24 hours
Baseline pH readings from Dx-pH measurement system. Measuring percentage reflux time at pH <4, <4.5, <5.0 and <6.0.
pH readings from Dx-pH measurement system
Time frame: 24 hours
Baseline pH readings from Dx-pH measurement system. Measuring the longest reflux period at pH <4, <4.5, <5.0 and <6.0.
7 secondary outcomes
Conventional oesophageal pH / impedance readings
Time frame: 24 hours
Conventional oesophageal pH / impedance readings
Time frame: 24 hours
Conventional oesophageal pH / impedance readings
Time frame: 24 hours
Conventional oesophageal pH / impedance readings
Time frame: 24 hours
Conventional oesophageal pH / impedance readings
Time frame: 24 hours
GORD related symptoms (GSQ-YC)
Time frame: At time of measurement
Pepsin (Peptest)
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iain A Bruce principal investigator
Royal Manchester Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experiemental diagnostic procedure: Dx-pH measurement system, Peptest assay and GORD symptom questionnaire in people with Gastro-oesophageal Reflux, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pH readings from Dx-pH measurement system (time frame: 24 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2019.