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

Not Applicable

Completed

• Conditions: Gastroesophageal Reflux Disease (GERD)
• Interventions: Procedure: Upper gastrointestinal endoscopy with biopsy and collection of refluxate; Procedure: Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring

• Registration Number: NCT02699060
• Lead Sponsor: Ivashkin Vladimir Trofimovich

Brief Summary

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

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 Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-12
• Study First Submitted QC: 2016-03-03
• Study First Posted: 2016-03-04
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Results First Submitted: 2020-02-11
• Status Verified: 2022-02
• Results First Submitted QC: 2022-02-17
• Last Update Submitted: 2022-02-17
• Results First Posted: 2022-02-18
• Last Update Posted: 2022-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NERD patients	Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring	Patients have typical reflux syndrome without esophageal injury.
EE patients	Upper gastrointestinal endoscopy with biopsy and collection of refluxate	Patients have erosion(s) or ulcer(s) in esophagus.
BE patients	Upper gastrointestinal endoscopy with biopsy and collection of refluxate	Patients have esophageal specialized intestinal metaplasia.
EE patients	Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring	Patients have erosion(s) or ulcer(s) in esophagus.
BE patients	Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring	Patients have esophageal specialized intestinal metaplasia.
NERD patients	Upper gastrointestinal endoscopy with biopsy and collection of refluxate	Patients have typical reflux syndrome without esophageal injury.

Primary Outcome Measures

Name	Time	Method
The Number of Reflux in GERD Patients	Day 4	We analyzed the number of acid and weakly acid reflux episodes in GERD patients

Trial Locations

Locations (2)

Moscow State University of Medicine and Dentistry named after A.I. Evdokimov; 🇷🇺 Moscow, Russian Federation

I.M.Sechenov First Moscow State Medical University; 🇷🇺 Moscow, Russian Federation