NCT05204303

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 24, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

September 2, 2022

Status Verified

August 1, 2022

Enrollment Period

11 months

First QC Date

January 10, 2022

Last Update Submit

August 30, 2022

Conditions

Laryngopharyngeal RefluxGastro Esophageal Reflux

Outcome Measures

Primary Outcomes (1)

  • Determine the detection strength of differences in fingerprints between the three participant groups.

    10-months

Secondary Outcomes (2)

  • Determine the differences in fingerprints between samples within one group to assess background noise.

    10-months

  • Determine the feasibility of mouthwash on Pandra platform.

    10-months

Study Arms (3)

Patients with symptoms of LPR and objective evidence of GORD

Diagnostic Test: 24-hour pH-impedance monitoringOther: Symptom questionnairesOther: ROME IV Diagnostic Questionnaire

Patients with symptoms of LPR and no objective evidence of GORD

Diagnostic Test: 24-hour pH-impedance monitoringOther: Symptom questionnairesOther: ROME IV Diagnostic Questionnaire

Healthy volunteers

Other: Symptom questionnairesOther: ROME IV Diagnostic Questionnaire

Interventions

24-hour pH-impedance monitoringDIAGNOSTIC_TEST

Ambulatory transnasal reflux device to detect reflux events in the oeosphagus and pharynx.

Patients with symptoms of LPR and no objective evidence of GORDPatients with symptoms of LPR and objective evidence of GORD
Symptom questionnairesOTHER

Reflux Symptom Index (RSI) Gastroesophageal Reflux Disease Questionnaire (GERDQ) Short-form Esophageal Hypervigilance and Anxiety Scale (SF-EHAS)

Healthy volunteersPatients with symptoms of LPR and no objective evidence of GORDPatients with symptoms of LPR and objective evidence of GORD
ROME IV Diagnostic QuestionnaireOTHER

A symptom-based questionnaire used to diagnose disorders of gut-brain interaction (DGBI)

Healthy volunteersPatients with symptoms of LPR and no objective evidence of GORDPatients with symptoms of LPR and objective evidence of GORD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Functional Gut Clinic

Manchester, Greater Manchester, M3 4BG, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Mouthwash (salivary oral rinse)

MeSH Terms

Conditions

Laryngopharyngeal RefluxGastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesLaryngeal DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Director

Study Record Dates

First Submitted

January 10, 2022

First Posted

January 24, 2022

Study Start

July 1, 2022

Primary Completion

June 1, 2023

Study Completion

July 1, 2023

Last Updated

September 2, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)