LPR Fluorescence Pilot

Last updated: August 30, 2022
Sponsor: The Functional Gut Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Esophageal Disorders

Heartburn (Pediatric)

Gastroesophageal Reflux Disease (Gerd)

Treatment

N/A

Clinical Study ID

NCT05204303
FGC-22-001
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Comparing the fluorescence signatures from mouthwash samples of patients with laryngopharyngeal reflux (LPR) and healthy volunteers.

Eligibility Criteria

Inclusion

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

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 pumpinhibitors, 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 LPRsymptoms.
  • Participant has NOT undergone nasoendoscopy within last 6 months OR does not have onescheduled 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 Design

Total Participants: 100
Study Start date:
July 01, 2022
Estimated Completion Date:
July 31, 2023

Study 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

Connect with a study center

  • The Functional Gut Clinic

    Manchester, Greater Manchester M3 4BG
    United Kingdom

    Active - Recruiting

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