Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2022-07-01
2023-07-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Patients with symptoms of LPR and objective evidence of GORD
24-hour pH-impedance monitoring
Ambulatory transnasal reflux device to detect reflux events in the oeosphagus and pharynx.
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)
Patients with symptoms of LPR and no objective evidence of GORD
24-hour pH-impedance monitoring
Ambulatory transnasal reflux device to detect reflux events in the oeosphagus and pharynx.
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)
Healthy volunteers
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)
Interventions
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24-hour pH-impedance monitoring
Ambulatory transnasal reflux device to detect reflux events in the oeosphagus and pharynx.
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)
Eligibility Criteria
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Inclusion Criteria
* 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)
* 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 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 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)
18 Years
ALL
Yes
Sponsors
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Rosa Biotech
UNKNOWN
The Functional Gut Clinic
OTHER
Responsible Party
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Dr Anthony Hobson
Clinical Director
Locations
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The Functional Gut Clinic
Manchester, Greater Manchester, United Kingdom
Countries
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Facility Contacts
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Other Identifiers
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FGC-22-001
Identifier Type: -
Identifier Source: org_study_id
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