---
title: Experimental Study to Determine the Effects of Human Refluxate on Macrophage Phenotype and Its Correlation With GERD
nct_id: NCT02699060
overall_status: COMPLETED
phase: NA
sponsor: Ivashkin Vladimir Trofimovich
study_type: INTERVENTIONAL
primary_condition: Gastroesophageal Reflux Disease (GERD)
countries: Russia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02699060.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02699060"
ct_last_update_post_date: 2022-02-18
last_seen_at: "2026-05-12T06:09:57.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT02699060](https://clinicaltrials.gov/study/NCT02699060)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 68
- **Lead Sponsor:** Ivashkin Vladimir Trofimovich
- **Collaborators:** Abbott
- **Conditions:** Gastroesophageal Reflux Disease (GERD)
- **Start Date:** 2016-02
- **Completion Date:** 2019-01
- **CT.gov Last Update:** 2022-02-18

## 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).

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **NERD patients** (EXPERIMENTAL) — Patients have typical reflux syndrome without esophageal injury.
- **EE patients** (EXPERIMENTAL) — Patients have erosion(s) or ulcer(s) in esophagus.
- **BE patients** (EXPERIMENTAL) — Patients have esophageal specialized intestinal metaplasia.

## Interventions

- **Upper gastrointestinal endoscopy with biopsy and collection of refluxate** (PROCEDURE) — 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 monitoring** (PROCEDURE) — 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 Outcomes

- **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

## Locations (2)

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

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.i.m.sechenov first moscow state medical university|moscow||russia` — added _(2026-05-12)_
- `locations.moscow state university of medicine and dentistry named after a.i. evdokimov|moscow||russia` — added _(2026-05-12)_

---

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