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

Primary Purpose

Gastroesophageal Reflux Disease (GERD)

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Upper gastrointestinal endoscopy with biopsy and collection of refluxate
Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring
Sponsored by
Ivashkin Vladimir Trofimovich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gastroesophageal Reflux Disease (GERD) focused on measuring GERD, Barrett's esophagus, macrophage, FSSG questionnaire

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • I.M.Sechenov First Moscow State Medical University
  • Moscow State University of Medicine and Dentistry named after A.I. Evdokimov

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

NERD patients

EE patients

BE patients

Arm Description

Patients have typical reflux syndrome without esophageal injury.

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

Patients have esophageal specialized intestinal metaplasia.

Outcomes

Primary Outcome Measures

The Number of Reflux in GERD Patients
We analyzed the number of acid and weakly acid reflux episodes in GERD patients

Secondary Outcome Measures

Full Information

First Posted
February 12, 2016
Last Updated
February 17, 2022
Sponsor
Ivashkin Vladimir Trofimovich
Collaborators
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT02699060
Brief Title
Experimental Study to Determine the Effects of Human Refluxate on Macrophage Phenotype and Its Correlation With GERD
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ivashkin Vladimir Trofimovich
Collaborators
Abbott

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease (GERD)
Keywords
GERD, Barrett's esophagus, macrophage, FSSG questionnaire

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NERD patients
Arm Type
Experimental
Arm Description
Patients have typical reflux syndrome without esophageal injury.
Arm Title
EE patients
Arm Type
Experimental
Arm Description
Patients have erosion(s) or ulcer(s) in esophagus.
Arm Title
BE patients
Arm Type
Experimental
Arm Description
Patients have esophageal specialized intestinal metaplasia.
Intervention Type
Procedure
Intervention Name(s)
Upper gastrointestinal endoscopy with biopsy and collection of refluxate
Other Intervention Name(s)
EGD (esophagogastroduodenoscopy) with esophagus biopsy
Intervention Description
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
Intervention Name(s)
Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring
Other Intervention Name(s)
HRM and 24-h esophageal pH monitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Number of Reflux in GERD Patients
Description
We analyzed the number of acid and weakly acid reflux episodes in GERD patients
Time Frame
Day 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical (patients) part Signed informed consent Gender: Male or Female Age: 18-65 years of age 3. Clinically and/or endoscopically confirmed diagnosis of GERD Exclusion Criteria: Clinical: (patient) 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. Female patients who are pregnant, planning to become pregnant or lactating 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. Participation in a clinical trial in the past 3 months Any condition which, in the opinion of investigator, makes the patient unsuitable for participation in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimir Ivashkin, MD,PhD,Prof.
Organizational Affiliation
I.M. Sechenov First Moscow State Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
I.M.Sechenov First Moscow State Medical University
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
Moscow State University of Medicine and Dentistry named after A.I. Evdokimov
City
Moscow
ZIP/Postal Code
127473
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21479676
Citation
Zhong YQ, Lin Y, Xu Z. Expression of IFN-gamma and IL-4 in the esophageal mucosa of patients with reflux esophagitis and Barrett's esophagus and their relationship with endoscopic and histologic grading. Dig Dis Sci. 2011 Oct;56(10):2865-70. doi: 10.1007/s10620-011-1696-9. Epub 2011 Apr 9.
Results Reference
background
PubMed Identifier
21590343
Citation
Kohata Y, Fujiwara Y, Machida H, Okazaki H, Yamagami H, Tanigawa T, Watanabe K, Watanabe T, Tominaga K, Wei M, Wanibuchi H, Arakawa T. Role of Th-2 cytokines in the development of Barrett's esophagus in rats. J Gastroenterol. 2011 Jul;46(7):883-93. doi: 10.1007/s00535-011-0405-y. Epub 2011 May 18.
Results Reference
background
PubMed Identifier
15842572
Citation
Gough MD, Ackroyd R, Majeed AW, Bird NC. Prediction of malignant potential in reflux disease: are cytokine polymorphisms important? Am J Gastroenterol. 2005 May;100(5):1012-8. doi: 10.1111/j.1572-0241.2005.40904.x.
Results Reference
background
PubMed Identifier
11889061
Citation
Fitzgerald RC, Onwuegbusi BA, Bajaj-Elliott M, Saeed IT, Burnham WR, Farthing MJ. Diversity in the oesophageal phenotypic response to gastro-oesophageal reflux: immunological determinants. Gut. 2002 Apr;50(4):451-9. doi: 10.1136/gut.50.4.451.
Results Reference
background
Links:
URL
http://www.mma.ru/en/
Description
I.M.Sechenov First Moscow State Medical University website

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

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