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

NCT02699060 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2022-02-18

Study results available
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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.

Conditions

  • Gastroesophageal Reflux Disease (GERD)

Interventions

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.

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.

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Ivashkin Vladimir Trofimovich

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • Russia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02699060 on ClinicalTrials.gov