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

February 17, 2022 updated by: Ivashkin Vladimir Trofimovich

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 119991
        • I.M.Sechenov First Moscow State Medical University
      • Moscow, Russian Federation, 127473
        • Moscow State University of Medicine and Dentistry named after A.I. Evdokimov

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NERD patients
Patients have typical reflux syndrome without esophageal injury.
Procedure: 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.
Other Names:
  • EGD (esophagogastroduodenoscopy) with esophagus biopsy
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.
Other Names:
  • HRM and 24-h esophageal pH monitoring
Experimental: EE patients
Patients have erosion(s) or ulcer(s) in esophagus.
Procedure: 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.
Other Names:
  • EGD (esophagogastroduodenoscopy) with esophagus biopsy
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.
Other Names:
  • HRM and 24-h esophageal pH monitoring
Experimental: BE patients
Patients have esophageal specialized intestinal metaplasia.
Procedure: 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.
Other Names:
  • EGD (esophagogastroduodenoscopy) with esophagus biopsy
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.
Other Names:
  • HRM and 24-h esophageal pH monitoring

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ivashkin Vladimir Trofimovich

Collaborators

Abbott

Investigators

  • Principal Investigator: Vladimir Ivashkin, MD,PhD,Prof., I.M. Sechenov First Moscow State Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

February 12, 2016

First Submitted That Met QC Criteria

March 3, 2016

First Posted (Estimate)

March 4, 2016

Study Record Updates

Last Update Posted (Actual)

February 18, 2022

Last Update Submitted That Met QC Criteria

February 17, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPIDKO19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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