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

Ivashkin Vladimir Trofimovich

Status: Completed

Conditions: Gastroesophageal Reflux Disease (GERD)

Treatments: Procedure: Upper gastrointestinal endoscopy with biopsy and collection of refluxate; Procedure: Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02699060

EPIDKO19

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 68 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Clinical (patients) part

1. Signed informed consent

2. Gender: Male or Female

3. Age: 18-65 years of age

4. 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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68 participants in 3 patient groups

NERD patients

Experimental group

Description:

Patients have typical reflux syndrome without esophageal injury.

Treatment:

Procedure: Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring

Procedure: Upper gastrointestinal endoscopy with biopsy and collection of refluxate

EE patients

Experimental group

Description:

Patients have erosion(s) or ulcer(s) in esophagus.

Treatment:

Procedure: Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring

Procedure: Upper gastrointestinal endoscopy with biopsy and collection of refluxate

BE patients

Experimental group

Description:

Patients have esophageal specialized intestinal metaplasia.

Treatment:

Procedure: Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring

Procedure: Upper gastrointestinal endoscopy with biopsy and collection of refluxate