---
title: The Role of HRM and Specific Biomarkers of Inflammation in the Diagnosis of Patients With Dysphagia and Suspected EoE
nct_id: NCT04803162
overall_status: UNKNOWN
sponsor: Wroclaw Medical University
study_type: OBSERVATIONAL
primary_condition: Eosinophilic Esophagitis
countries: Poland
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04803162.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04803162"
ct_last_update_post_date: 2021-03-17
last_seen_at: "2026-05-12T07:00:47.714Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The Role of HRM and Specific Biomarkers of Inflammation in the Diagnosis of Patients With Dysphagia and Suspected EoE

**Official Title:** The Role of High-resolution Esophageal Manometry and Specific Biomarkers of Inflammation in the Diagnosis of Patients With Dysphagia and Suspected Eosinophilic Esophagitis

**NCT ID:** [NCT04803162](https://clinicaltrials.gov/study/NCT04803162)

## Key Facts

- **Status:** UNKNOWN
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 58
- **Lead Sponsor:** Wroclaw Medical University
- **Conditions:** Eosinophilic Esophagitis
- **Start Date:** 2017-11-14
- **Completion Date:** 2021-12
- **CT.gov Last Update:** 2021-03-17

## Brief Summary

The aim of the project is to assess the correlation between the results of high-resolution oesophageal manometry and specific biomarkers of inflammation (eotaxin 3, major basic protein, IL-5, IL-13, TGF-beta1) with symptoms of dysphagia, endoscopic and histological features and the assessment of quality of life in patients with eosinophilic esophagitis.

Research hypothesis: The results of high resolution esophageal manometry (HRM) and specific inflammatory biomarkers correlate with symptoms of dysphagia, endoscopic and histological features, and assessment of quality of life in patients with eosinophilic oesophagitis. HRM, along with the determination of specific inflammatory biomarkers present in the peripheral blood, may serve as a less invasive method of assessing the effectiveness of the treatment of eosinophilic oesophagitis in relation to the currently used endoscopic examinations.

## Eligibility

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

```
Inclusion Criteria:

* patients over 18 years of age,
* patients referred for endoscopic diagnostics due to dysphagia.

Exclusion Criteria:

* already diagnosed chronic diseases with possible eosinophilic infiltration of the gastrointestinal tract (eosinophilic esophagitis, eosinophilic gastroenteritis, Crohn's disease, celiac disease),
* rheumatological, dermatological and genetic disorders with possible peripheral eosinophilia,
* dysphagia caused by a diagnosed neoplastic infiltration of the esophagus.
```

## Arms

- **patients with eosinophilic esophagitis** — Each project participant completed a health and existing disease questionnaire and the GIQLI. Quantification of IL-5, IL-13 and TGF-β1 serum levels was performed using enzyme immunoassays. From each participant during the esophagogastroduodenoscopy, 6 oesophageal mucosa biopsy specimens were collected. The obtained material was sent for histopathological examination to assess peak eosinophil count (PEC). After completing medical examinations, the project participants were divided according to the histopathological criterion's fulfillment for the diagnosis of EoE. Patients with ≥15 eosinophils/HPF in the biopsy samples constituted the group of patients with EoE, while the remaining patients - the control group. EoE patients were then treated for 8 weeks with PPs - omeprazole in the dose of 20 mg twice daily. After 8 weeks, each patient in the EoE group again passed all the tests (the protocols were identical to those used for qualifying patients to the project).
- **patients without eosinophilic esophagitis** — Each project participant completed a health and existing disease questionnaire and the GIQLI. Quantification of IL-5, IL-13 and TGF-β1 serum levels was performed using enzyme immunoassays. From each participant during the esophagogastroduodenoscopy, 6 oesophageal mucosa biopsy specimens were collected. The obtained material was sent for histopathological examination to assess peak eosinophil count (PEC). After completing medical examinations, the project participants were divided according to the histopathological criterion's fulfillment for the diagnosis of EoE. Patients with ≥15 eosinophils/HPF in the biopsy samples constituted the group of patients with EoE, while the remaining patients - the control group.

## Interventions

- **High-resolution manometry** (DIAGNOSTIC_TEST) — The parameters of high-resolution esophageal manometry will be compared between EoE patients and controls.
- **Serum biomarkers** (DIAGNOSTIC_TEST) — The serum levels of IL-5, IL-13, TGF-β1, MBP and eotaxin 3 will be compared between EoE patients and controls.
- **Gastrointestinal Quality of Life index** (DIAGNOSTIC_TEST) — The Gastrointestinal Quality of Life index (GIQLI) will be compared between EoE patients and controls.
- **Omeprazole 20 MG Oral Tablet** (DRUG) — The parameters of high-resolution esophageal manometry and serum levels of IL-5, IL-13, TGF-β1, MBP and eotaxin 3 will be compared in the group of patients with EoE at enrollment in the project and after 3 months of treatment with PPIs.

## Primary Outcomes

- **High-resolution manometry** _(time frame: 3 months)_ — The parameters of high-resolution esophageal manometry will be compared between EoE patients and controls.
- **Serum biomarkers** _(time frame: 3 months)_ — The serum levels of IL-5, IL-13, TGF-β1, MBP and eotaxin 3 will be compared between EoE patients and controls.
- **Gastrointestinal Quality of Life index** _(time frame: 3 months)_ — The Gastrointestinal Quality of Life index (GIQLI) will be compared between EoE patients and controls.

## Secondary Outcomes

- **High-resolution manometry in the group of patients with EoE** _(time frame: 3 months)_
- **Serum biomarkers in the group of patients with EoE** _(time frame: 3 months)_

## Locations (1)

- Department of Gastroenterology and Hepatology, Wroclaw Medical University, Wroclaw, Borowska 213, Poland

## 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.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.department of gastroenterology and hepatology, wroclaw medical university|wroclaw|borowska 213|poland` — added _(2026-05-12)_

---

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