Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-31 @ 8:21 AM
Study NCT ID:
NCT05204303
Status:
UNKNOWN
Last Update Posted:
2022-09-02
First Post:
2022-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LPR Fluorescence Pilot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057045', 'term': 'Laryngopharyngeal Reflux'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Mouthwash (salivary oral rinse)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-30', 'studyFirstSubmitDate': '2022-01-10', 'studyFirstSubmitQcDate': '2022-01-10', 'lastUpdatePostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the detection strength of differences in fingerprints between the three participant groups.', 'timeFrame': '10-months'}], 'secondaryOutcomes': [{'measure': 'Determine the differences in fingerprints between samples within one group to assess background noise.', 'timeFrame': '10-months'}, {'measure': 'Determine the feasibility of mouthwash on Pandra platform.', 'timeFrame': '10-months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Laryngopharyngeal Reflux', 'Gastro Esophageal Reflux']}, 'descriptionModule': {'briefSummary': 'Comparing the fluorescence signatures from mouthwash samples of patients with laryngopharyngeal reflux (LPR) and healthy volunteers.', 'detailedDescription': '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:\n\nA. 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Healthy Volunteers\n\nInclusion Criteria:\n\n* Participant is Aged 18 or above\n* Participant has capacity to understand written English\n* Participant is not on regular prescription medicines\n* Participant has an RSI score of 0\n* Participant has a body mass index (BMI) of 18.5 - 34.9 kg/m2 (bounds included)\n\nExclusion Criteria:\n\n* Participant has experienced any symptoms of LPR or GORD symptoms in the past year\n* Participant has taken any medication for GORD/LPR in the past year (e.g. proton pump inhibitors, h2 antagonists, over the counter antacids)\n* Participant has active oral disease\n* Participant has a significant medical diagnosis\n\nPatients with symptoms of LPR\n\nInclusion Criteria:\n\n* Participant is Aged 18 or above\n* Participant has capacity to understand written English\n* Participant has an RSI score of \\>13\n* Participant has a body mass index (BMI) of 18.5 - 34.9 kg/m2 (bounds included\n* Participant has been referred for 24hr ambulatory pH-impedance monitoring\n\nExclusion Criteria:\n\n* Participant has active oral disease\n* Participant has other ongoing health problems that could account for their LPR symptoms.\n* Participant has NOT undergone nasoendoscopy within last 6 months OR does not have one scheduled within next 6 weeks\n* Previous antireflux surgery (e.g. fundoplication or magnetic sphincter augmentation)\n* Previous bariatric surgery (e.g. gastric bypass or sleeve gastrectomy)'}, 'identificationModule': {'nctId': 'NCT05204303', 'briefTitle': 'LPR Fluorescence Pilot', 'organization': {'class': 'OTHER', 'fullName': 'The Functional Gut Clinic'}, 'officialTitle': 'Analysis of Mouthwash Samples From Laryngopharyngeal Reflux (LPR) Patients and Healthy Volunteers Using Barrel-array Diagnostics', 'orgStudyIdInfo': {'id': 'FGC-22-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with symptoms of LPR and objective evidence of GORD', 'interventionNames': ['Diagnostic Test: 24-hour pH-impedance monitoring', 'Other: Symptom questionnaires', 'Other: ROME IV Diagnostic Questionnaire']}, {'label': 'Patients with symptoms of LPR and no objective evidence of GORD', 'interventionNames': ['Diagnostic Test: 24-hour pH-impedance monitoring', 'Other: Symptom questionnaires', 'Other: ROME IV Diagnostic Questionnaire']}, {'label': 'Healthy volunteers', 'interventionNames': ['Other: Symptom questionnaires', 'Other: ROME IV Diagnostic Questionnaire']}], 'interventions': [{'name': '24-hour pH-impedance monitoring', 'type': 'DIAGNOSTIC_TEST', 'description': 'Ambulatory transnasal reflux device to detect reflux events in the oeosphagus and pharynx.', 'armGroupLabels': ['Patients with symptoms of LPR and no objective evidence of GORD', 'Patients with symptoms of LPR and objective evidence of GORD']}, {'name': 'Symptom questionnaires', 'type': 'OTHER', 'description': 'Reflux Symptom Index (RSI) Gastroesophageal Reflux Disease Questionnaire (GERDQ) Short-form Esophageal Hypervigilance and Anxiety Scale (SF-EHAS)', 'armGroupLabels': ['Healthy volunteers', 'Patients with symptoms of LPR and no objective evidence of GORD', 'Patients with symptoms of LPR and objective evidence of GORD']}, {'name': 'ROME IV Diagnostic Questionnaire', 'type': 'OTHER', 'description': 'A symptom-based questionnaire used to diagnose disorders of gut-brain interaction (DGBI)', 'armGroupLabels': ['Healthy volunteers', 'Patients with symptoms of LPR and no objective evidence of GORD', 'Patients with symptoms of LPR and objective evidence of GORD']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M3 4BG', 'city': 'Manchester', 'state': 'Greater Manchester', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Jordan Haworth, BSc', 'role': 'CONTACT', 'email': 'jordan@functionalgutdiagnostics.com', 'phone': '01613027777'}, {'name': 'Jordan J Haworth, BSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sam Treadway, MSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The Functional Gut Clinic', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Functional Gut Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rosa Biotech', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Director', 'investigatorFullName': 'Dr Anthony Hobson', 'investigatorAffiliation': 'The Functional Gut Clinic'}}}}