Analysis of Mouthwash Samples From Laryngopharyngeal Reflux (LPR) Patients and Healthy Volunteers Using Barrel-array Diagnostics
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Determine the detection strength of differences in fingerprints between the three participant groups.
研究概览
简要总结
Comparing the fluorescence signatures from mouthwash samples of patients with laryngopharyngeal reflux (LPR) and healthy volunteers.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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)
结局指标
主要结局
Determine the detection strength of differences in fingerprints between the three participant groups.
时间窗: 10-months
次要结局
- Determine the feasibility of mouthwash on Pandra platform.(10-months)
- Determine the differences in fingerprints between samples within one group to assess background noise.(10-months)
研究者
Dr Anthony Hobson
Clinical Director
The Functional Gut Clinic