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

Ivashkin Vladimir Trofimovich68 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Gastroesophageal Reflux Disease (GERD)

Interventions

Upper gastrointestinal endoscopy with biopsy and collection of refluxatePROCEDURE

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.

Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoringPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: Clinical (patients) part 1. Signed informed consent 2. Gender: Male or Female 3. Age: 18-65 years of age 3\. Clinically and/or endoscopically confirmed diagnosis of GERD Exclusion Criteria: Clinical: (patient) 1. 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. 2. Female patients who are pregnant, planning to become pregnant or lactating 3. 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. 4. Participation in a clinical trial in the past 3 months 5. Any condition which, in the opinion of investigator, makes the patient unsuitable for participation in the study

Locations (2)

I.M.Sechenov First Moscow State Medical University

Moscow, Russia

Moscow State University of Medicine and Dentistry named after A.I. Evdokimov

Moscow, Russia

Outcomes

Primary Outcomes

The Number of Reflux in GERD Patients

We analyzed the number of acid and weakly acid reflux episodes in GERD patients

Time frame: Day 4

Data from ClinicalTrials.gov

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