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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2019-01-31

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.

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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).

Conditions

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Gastroesophageal Reflux Disease (GERD)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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NERD patients

Patients have typical reflux syndrome without esophageal injury.

Group Type EXPERIMENTAL

Upper gastrointestinal endoscopy with biopsy and collection of refluxate

Intervention Type PROCEDURE

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 monitoring

Intervention Type PROCEDURE

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.

EE patients

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

Group Type EXPERIMENTAL

Upper gastrointestinal endoscopy with biopsy and collection of refluxate

Intervention Type PROCEDURE

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 monitoring

Intervention Type PROCEDURE

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.

BE patients

Patients have esophageal specialized intestinal metaplasia.

Group Type EXPERIMENTAL

Upper gastrointestinal endoscopy with biopsy and collection of refluxate

Intervention Type PROCEDURE

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 monitoring

Intervention Type PROCEDURE

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.

Interventions

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Upper gastrointestinal endoscopy with biopsy and collection of refluxate

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.

Intervention Type PROCEDURE

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

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.

Intervention Type PROCEDURE

Other Intervention Names

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EGD (esophagogastroduodenoscopy) with esophagus biopsy HRM and 24-h esophageal pH monitoring

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No