Healthy Volunteers
Conditions
Keywords
Transient lower esophageal sphincter relaxation, high resolution manometry, dentsleeve probe, healthy volunteers
Brief summary
Transient lower esophageal sphincter relaxations (tLESr) are the main mechanism of gastro-oesophageal reflux disease. They occur without any deglutition in patients but also in healthy volunteers. They are induced by meal. The gold standard to detect tLESr is esophageal manometry using perfused Dentsleeve probe. Esophageal high resolution manometry with solid state sensors was developed in the 90s. The examination is easier and more accurate than perfused manometry. The aim of this study is to validate in healthy volunteers the use of high resolution manometry (Sierra Scientific Instruments, California CA) to detect tLESr.
Interventions
DEVICEEsophageal high resolution manometry associated or not with manometry with perfused Dentsleeve probe (as determined by randomization)
Visit V0 (day 0 - 2 to 14 days): * Subject selection * Obtaining of written informed consent Visit V1 (day 0): * Fasting subject * Randomization to determine the examination order * Esophageal high resolution manometry (Sierra Scientific Instruments, California CA) associated or not with manometry with perfused Dentsleeve probe (as determined by randomisation): 3-hour recording (1 hour fasting, ingestion of a 600-kcal liquid meal in 10 minutes, 2 hours post prandial) Visit V2 (day 0 + 1 day): Phone contact Visit V3 (day 0 + 2 to 7 days): * Same as V1 Visit V4 (V3 + 1 day): Phone contact and end of the study
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or Female between 18 and 60 years 2. Subject without typical or atypical symptoms of gastro-esophageal reflux disease (heartburn, regurgitation, epigastric pain, chest pain, chronic cough, pharyngeal pain) 3. Subject without any medication (except oral contraception) 4. Subject without previous digestive surgery history (except appendicectomy) 5. Capability to pass manometric probes through each nostril 6. Subject with health insurance 7. Written informed consent 8. No participation to another study at the same time
Exclusion criteria
1. Age under 18 years or upper 60 2. Pregnant woman or lactation 3. Incapability to give consent 4. No written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is to demonstrate that high resolution manometry allows the detection of meal-induced tLESr. All recordings will be analyzed at the end of each examination and reviewed at the end of the enrolment. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the number of tLESr detected by high resolution manometry and those detected by manometry with perfused dentsleeve probe. | — |
| To define the characteristics (duration, relaxation amplitude) of high resolution manometry-detected tLESr. | — |
Countries
France
Contacts
Primary ContactROMAN Sabine, MD
Outcome results
None listed