LPR Fluorescence Pilot

August 30, 2022 updated by: Dr Anthony Hobson, The Functional Gut Clinic

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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:

A. 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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M3 4BG
        • Recruiting
        • The Functional Gut Clinic
        • Contact:
        • Sub-Investigator:
          • Jordan J Haworth, BSc
        • Sub-Investigator:
          • Sam Treadway, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Healthy Volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Inclusion Criteria:

  • Participant is Aged 18 or above
  • 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

Exclusion Criteria:

  • Participant has active oral disease
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy volunteers
Other: Symptom questionnaires
Reflux Symptom Index (RSI) Gastroesophageal Reflux Disease Questionnaire (GERDQ) Short-form Esophageal Hypervigilance and Anxiety Scale (SF-EHAS)
Other: ROME IV Diagnostic Questionnaire
A symptom-based questionnaire used to diagnose disorders of gut-brain interaction (DGBI)
Patients with symptoms of LPR and objective evidence of GORD
Diagnostic test: 24-hour pH-impedance monitoring
Ambulatory transnasal reflux device to detect reflux events in the oeosphagus and pharynx.
Other: Symptom questionnaires
Reflux Symptom Index (RSI) Gastroesophageal Reflux Disease Questionnaire (GERDQ) Short-form Esophageal Hypervigilance and Anxiety Scale (SF-EHAS)
Other: ROME IV Diagnostic Questionnaire
A symptom-based questionnaire used to diagnose disorders of gut-brain interaction (DGBI)
Patients with symptoms of LPR and no objective evidence of GORD
Diagnostic test: 24-hour pH-impedance monitoring
Ambulatory transnasal reflux device to detect reflux events in the oeosphagus and pharynx.
Other: Symptom questionnaires
Reflux Symptom Index (RSI) Gastroesophageal Reflux Disease Questionnaire (GERDQ) Short-form Esophageal Hypervigilance and Anxiety Scale (SF-EHAS)
Other: ROME IV Diagnostic Questionnaire
A symptom-based questionnaire used to diagnose disorders of gut-brain interaction (DGBI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the detection strength of differences in fingerprints between the three participant groups.
Time Frame: 10-months
10-months

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine the differences in fingerprints between samples within one group to assess background noise.
Time Frame: 10-months
10-months
Determine the feasibility of mouthwash on Pandra platform.
Time Frame: 10-months
10-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Functional Gut Clinic

Collaborators

Rosa Biotech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2022

Primary Completion (ANTICIPATED)

June 1, 2023

Study Completion (ANTICIPATED)

July 1, 2023

Study Registration Dates

First Submitted

January 10, 2022

First Submitted That Met QC Criteria

January 10, 2022

First Posted (ACTUAL)

January 24, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 2, 2022

Last Update Submitted That Met QC Criteria

August 30, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FGC-22-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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