Laryngopharyngeal RefluxNCT05204303
LPR Fluorescence Pilot
An observational study of Laryngopharyngeal Reflux and Gastro Esophageal Reflux, run by The Functional Gut Clinic at 1 site in United Kingdom.
Trial summary
Comparing the fluorescence signatures from mouthwash samples of patients with laryngopharyngeal reflux (LPR) and healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Laryngopharyngeal Reflux, Gastro Esophageal Reflux
- What is being tested?
- 24-hour pH-impedance monitoring, Symptom questionnaires and ROME IV Diagnostic Questionnaire
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2022to Jul 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with LPR symptoms referred for ambulatory pH-impedance monitoring will be separated into two groups following completion of the pH-impedance test: those with objective evidence of GORD and those without objective evidence of GORD.
Who may be able to join
- Participant is Aged 18 or above
- Participant has capacity to understand written English
- Participant is not on regular prescription medicines
- Participant has an RSI score of 0
- Participant has a body mass index (BMI) of 18.5 - 34.9 kg/m2 (bounds included)
- Participant is Aged 18 or above
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- Participant has capacity to understand written English
- Participant has an RSI score of >13
- Participant has a body mass index (BMI) of 18.5 - 34.9 kg/m2 (bounds included
- Participant has been referred for 24hr ambulatory pH-impedance monitoring
Who cannot join
- Participant has experienced any symptoms of LPR or GORD symptoms in the past year
- Participant has taken any medication for GORD/LPR in the past year (e.g. proton pump inhibitors, h2 antagonists, over the counter antacids)
- Participant has active oral disease
- Participant has a significant medical diagnosis
- Patients with symptoms of LPR
- Participant has active oral disease
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- Participant has other ongoing health problems that could account for their LPR symptoms.
- Participant has NOT undergone nasoendoscopy within last 6 months OR does not have one scheduled within next 6 weeks
- Previous antireflux surgery (e.g. fundoplication or magnetic sphincter augmentation)
- Previous bariatric surgery (e.g. gastric bypass or sleeve gastrectomy)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The Functional Gut Clinic
Manchester, Greater Manchester, M3 4BG
Jordan Haworth, BSc, 01613027777, jordan@functionalgutdiagnostics.com
Jordan J Haworth, BSc
About this study
Official title: Analysis of Mouthwash Samples From Laryngopharyngeal Reflux (LPR) Patients and Healthy Volunteers Using Barrel-array Diagnostics
Comparing the fluorescence signatures from mouthwash samples of patients with laryngopharyngeal reflux (LPR) and healthy volunteers.
Read the detailed description
The investigators aim to test if the biosensing platform Pandra, developed by Rosa Biotech, may be suitable to distinguish patients with LPR symptoms, both with and without objective evidence of gastroesophageal reflux disease (GORD), vs healthy volunteers due to their expected inflammation and cell changes in the laryngo-pharyngeal region. The investigators intend to analyse 20 samples of mouthwash solutions from each of the following groups:
- Patients with symptoms of LPR and objective evidence of GORD B. Patients with symptoms of LPR and no objective evidence of GORD C. Healthy volunteer group
- Conditions
- Laryngopharyngeal Reflux, Gastro Esophageal Reflux
- Being tested
- 24-hour pH-impedance monitoring, Symptom questionnaires, ROME IV Diagnostic Questionnaire
- Medical subject headings
- Laryngopharyngeal Reflux, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24-hour pH-impedance monitoringDiagnostic test
Ambulatory transnasal reflux device to detect reflux events in the oeosphagus and pharynx.
Symptom questionnairesOther
Reflux Symptom Index (RSI) Gastroesophageal Reflux Disease Questionnaire (GERDQ) Short-form Esophageal Hypervigilance and Anxiety Scale (SF-EHAS)
ROME IV Diagnostic QuestionnaireOther
A symptom-based questionnaire used to diagnose disorders of gut-brain interaction (DGBI)
| Study group | Role | What they receive |
|---|---|---|
| Patients with symptoms of LPR and objective evidence of GORD | Not described Receives: Diagnostic Test: 24-hour pH-impedance monitoring; Other: Symptom questionnaires; Other: ROME IV Diagnostic Questionnaire | |
| Patients with symptoms of LPR and no objective evidence of GORD | Not described Receives: Diagnostic Test: 24-hour pH-impedance monitoring; Other: Symptom questionnaires; Other: ROME IV Diagnostic Questionnaire | |
| Healthy volunteers | Not described Receives: Other: Symptom questionnaires; Other: ROME IV Diagnostic Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the detection strength of differences in fingerprints between the three participant groups.
Measured: 10-months
Secondary outcomes (2)
Determine the differences in fingerprints between samples within one group to assess background noise.
Measured: 10-months
Determine the feasibility of mouthwash on Pandra platform.
Measured: 10-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start1 Jul 2022
- Primary completionJun 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngopharyngeal 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Functional Gut Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Rosa Biotech
- Responsible party
- Principal investigator, Dr Anthony Hobson, The Functional Gut Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204303
- Sponsor's protocol ID
- FGC-22-001
- Status last verified
- Aug 2022
- First submitted
- 10 Jan 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Mouthwash Samples From Laryngopharyngeal Reflux (LPR) Patients and Healthy Volunteers Using Barrel-array Diagnostics
- ClinicalTrials.gov ID
- NCT05204303
- Acronym / sponsor ID
- FGC-22-001
- Conditions
- Laryngopharyngeal Reflux, Gastro Esophageal Reflux
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Functional Gut ClinicUniversity, hospital or other
- Collaborators
- Rosa Biotech
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 24 Jan 2022 (actual)
- 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.
Comparing the fluorescence signatures from mouthwash samples of patients with laryngopharyngeal reflux (LPR) and healthy volunteers.
Detailed description
The investigators aim to test if the biosensing platform Pandra, developed by Rosa Biotech, may be suitable to distinguish patients with LPR symptoms, both with and without objective evidence of gastroesophageal reflux disease (GORD), vs healthy volunteers due to their expected inflammation and cell changes in the laryngo-pharyngeal region. The investigators intend to analyse 20 samples of mouthwash solutions from each of the following groups:
- Patients with symptoms of LPR and objective evidence of GORD B. Patients with symptoms of LPR and no objective evidence of GORD C. Healthy volunteer group
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with symptoms of LPR and objective evidence of GORD | – | Diagnostic Test: 24-hour pH-impedance monitoring, Other: Symptom questionnaires, Other: ROME IV Diagnostic Questionnaire |
| Patients with symptoms of LPR and no objective evidence of GORD | – | Diagnostic Test: 24-hour pH-impedance monitoring, Other: Symptom questionnaires, Other: ROME IV Diagnostic Questionnaire |
| Healthy volunteers | – | Other: Symptom questionnaires, Other: ROME IV Diagnostic Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with LPR symptoms referred for ambulatory pH-impedance monitoring will be separated into two groups following completion of the pH-impedance test: those with objective evidence of GORD and those without objective evidence of GORD.
Key inclusion criteria (10 listed)
- Participant is Aged 18 or above
- Participant has capacity to understand written English
- Participant is not on regular prescription medicines
- Participant has an RSI score of 0
- Participant has a body mass index (BMI) of 18.5 - 34.9 kg/m2 (bounds included)
Key exclusion criteria (10 listed)
- Participant has experienced any symptoms of LPR or GORD symptoms in the past year
- Participant has taken any medication for GORD/LPR in the past year (e.g. proton pump inhibitors, h2 antagonists, over the counter antacids)
- Participant has active oral disease
- Participant has a significant medical diagnosis
- Patients with symptoms of LPR
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 |
|---|---|---|
| 24-hour pH-impedance monitoringAmbulatory transnasal reflux device to detect reflux events in the oeosphagus and pharynx. | Diagnostic test | Patients with symptoms of LPR and no objective evidence of GORD, Patients with symptoms of LPR and objective evidence of GORD |
| Symptom questionnairesReflux Symptom Index (RSI) Gastroesophageal Reflux Disease Questionnaire (GERDQ) Short-form Esophageal Hypervigilance and Anxiety Scale (SF-EHAS) | Other | Healthy volunteers, Patients with symptoms of LPR and no objective evidence of GORD, Patients with symptoms of LPR and objective evidence of GORD |
| ROME IV Diagnostic QuestionnaireA symptom-based questionnaire used to diagnose disorders of gut-brain interaction (DGBI) | Other | Healthy volunteers, Patients with symptoms of LPR and no objective evidence of GORD, Patients with symptoms of LPR and objective evidence of GORD |
Primary outcome
Determine the detection strength of differences in fingerprints between the three participant groups.
Time frame: 10-months
2 secondary outcomes
Determine the differences in fingerprints between samples within one group to assess background noise.
Time frame: 10-months
Determine the feasibility of mouthwash on Pandra platform.
Time frame: 10-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laryngopharyngeal Reflux and Gastro Esophageal Reflux, run by The Functional Gut Clinic 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 10 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 2 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the detection strength of differences in fingerprints between the three participant groups. (time frame: 10-months). 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 2 Sep 2022.