CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 68 enrolled
Drug / intervention
Upper gastrointestinal endoscopy with biopsy and collection of refluxate +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02699060
NCT02699060N/ACompleted
CompareCT.gov

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

Ivashkin Vladimir Trofimovich·interventional·Posted Mar 4, 2016·Updated Feb 18, 2022

In Brief

A clinical study evaluating Upper gastrointestinal endoscopy with biopsy and collection of refluxate and Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring for Gastroesophageal Reflux Disease (GERD). Completed, enrolled 68 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroesophageal Reflux Disease (GERD)
CountriesRussia
CollaboratorsAbbott

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 4, 2016
Enrollment StartFeb 1, 2016
Primary CompletionJan 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 10.3 years ago

Interventions

Upper gastrointestinal endoscopy with biopsy and collection of refluxateprocedure

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 monitoringprocedure

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.