Experimental Study to Determine the Effects of Human Refluxate on Macrophage Phenotype and Its Correlation With GERD

Study Overview
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Brief Summary
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This study is proposed to evaluate the role of motoric dysfunctions and type of refluxate in GERD patients, analyzed the blood monocyte/macrophage phenotypes of gastroesophageal reflux diseases (GERD) patients.

Detailed Description
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Patients with non-erosive gastroesophageal reflux disease (NERD), erosive esophagitis (EE) and Barrett esophagus (BE) were enrolled. We investigated blood monocyte/macrophage phenotype in patients with different forms of GERD. We analysed of macrophages phenotype by CD25, CD80, CD163, CD206 expression for M2 macrophages. All patients underwent upper gastrointestinal endoscopy with esophagus biopsy. GERD patients underwent esophageal high-resolution manometry (HRM) with a 22-channel water-perfused catheter and Solar GI system (Medical Measurements Systems, Enschede, the Netherlands) and 24-hour impedance and pH monitoring using the Ohmega Ambulatory Impedance pH Recorder (Medical Measurements Systems).

Official Title
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Experimental Study to Determine the Effects of Human Refluxate (Biliary, Gastric, Duodenogastric) on Macrophage Phenotype and Its Correlation With Different Forms of GERD: Motility Talent Group Study

Conditions
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Gastroesophageal Reflux Disease (GERD)

Intervention / Treatment
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* Procedure: Upper gastrointestinal endoscopy with biopsy and collection of refluxate
* Procedure: Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical (patients) part Signed informed consent Gender: Male or Female Age: 18-65 years of age 3. Clinically and/or endoscopically confirmed diagnosis of GERD Exclusion Criteria: Clinical: (patient) Current treatment with proton pump inhibitors and/or histamine-2 receptor antagonists. These treatments should have been stopped at least 1 week prior to study inclusion. Female patients who are pregnant, planning to become pregnant or lactating Any acute diseases or conditions, exacerbations of concomitant chronic diseases (including but not limited to inflammatory bowel disease (IBD), ulcer disease etc.) at study start/inclusion and/or which are not resolved 14 days prior to study-enrolment. Participation in a clinical trial in the past 3 months Any condition which, in the opinion of investigator, makes the patient unsuitable for participation in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NERD patients<br>Patients have typical reflux syndrome without esophageal injury. | Procedure: Upper gastrointestinal endoscopy with biopsy and collection of refluxate<br>* we analyzed esophageal mucosa, expression of inflammatory changes, location, size, number of mucosal defects, as well as the appearance of the gastric and duodenal mucosa.<br>* Other names: EGD (esophagogastroduodenoscopy) with esophagus biopsy;Procedure: Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring<br>* we analyzed following HRM parameters: the distal contractile integral (DCI), the lower esophageal sphincter resting pressure (LES RP) and standard measuring parameters were be collected: percentage of total time when pH was <4, longest reflux event, number of reflux events longer than 5 minutes, and number of reflux episodes in 24 hours.<br>* Other names: HRM and 24-h esophageal pH monitoring;|
| Experimental: EE patients<br>Patients have erosion(s) or ulcer(s) in esophagus. | Procedure: Upper gastrointestinal endoscopy with biopsy and collection of refluxate<br>* we analyzed esophageal mucosa, expression of inflammatory changes, location, size, number of mucosal defects, as well as the appearance of the gastric and duodenal mucosa.<br>* Other names: EGD (esophagogastroduodenoscopy) with esophagus biopsy;Procedure: Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring<br>* we analyzed following HRM parameters: the distal contractile integral (DCI), the lower esophageal sphincter resting pressure (LES RP) and standard measuring parameters were be collected: percentage of total time when pH was <4, longest reflux event, number of reflux events longer than 5 minutes, and number of reflux episodes in 24 hours.<br>* Other names: HRM and 24-h esophageal pH monitoring;|
| Experimental: BE patients<br>Patients have esophageal specialized intestinal metaplasia. | Procedure: Upper gastrointestinal endoscopy with biopsy and collection of refluxate<br>* we analyzed esophageal mucosa, expression of inflammatory changes, location, size, number of mucosal defects, as well as the appearance of the gastric and duodenal mucosa.<br>* Other names: EGD (esophagogastroduodenoscopy) with esophagus biopsy;Procedure: Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring<br>* we analyzed following HRM parameters: the distal contractile integral (DCI), the lower esophageal sphincter resting pressure (LES RP) and standard measuring parameters were be collected: percentage of total time when pH was <4, longest reflux event, number of reflux events longer than 5 minutes, and number of reflux episodes in 24 hours.<br>* Other names: HRM and 24-h esophageal pH monitoring;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Reflux in GERD Patients | We analyzed the number of acid and weakly acid reflux episodes in GERD patients | Day 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD, Barrett's esophagus, macrophage, FSSG questionnaire