LPR Fluorescence Pilot

Gastro Esophageal Reflux Clinical Trial

Official title:

Analysis of Mouthwash Samples From Laryngopharyngeal Reflux (LPR) Patients and Healthy Volunteers Using Barrel-array Diagnostics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05204303
• Other study ID #: FGC-22-001
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: July 2023

Study information

• Verified date: August 2022
• Source: The Functional Gut Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Gastro Esophageal Reflux
• Gastroesophageal Reflux
• Laryngopharyngeal Reflux

Intervention

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)
• ROME IV Diagnostic Questionnaire
A symptom-based questionnaire used to diagnose disorders of gut-brain interaction (DGBI)

Locations

Country	Name	City	State
United Kingdom	The Functional Gut Clinic	Manchester	Greater Manchester

Sponsors (2)

Lead Sponsor	Collaborator
The Functional Gut Clinic	Rosa Biotech

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the detection strength of differences in fingerprints between the three participant groups.		10-months
Secondary	Determine the differences in fingerprints between samples within one group to assess background noise.		10-months
Secondary	Determine the feasibility of mouthwash on Pandra platform.		10-months