Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-24 @ 7:11 PM
NCT ID:
NCT05204303
Eligibility Criteria:
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)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05204303
Study Brief:
Protocol Section:
NCT05204303