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The Role of HRM and Specific Biomarkers of Inflammation in the Diagnosis of Patients With Dysphagia and Suspected EoE

NCT04803162 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 58

Last updated 2021-03-17

No results posted yet for this study

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.

Conditions

  • Eosinophilic Esophagitis

Interventions

DIAGNOSTIC_TEST

High-resolution manometry

The parameters of high-resolution esophageal manometry will be compared between EoE patients and controls.

DIAGNOSTIC_TEST

Serum biomarkers

The serum levels of IL-5, IL-13, TGF-β1, MBP and eotaxin 3 will be compared between EoE patients and controls.

DIAGNOSTIC_TEST

Gastrointestinal Quality of Life index

The Gastrointestinal Quality of Life index (GIQLI) will be compared between EoE patients and controls.

DRUG

Omeprazole 20 MG Oral Tablet

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.

Sponsors & Collaborators

  • Wroclaw Medical University

    lead OTHER

Principal Investigators

  • Dorota Waśko-Czopnik, PhD MD · Department of Gastroenterology and Hepatology, Wroclaw Medical University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-14
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Poland

Study Locations

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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 NCT04803162 on ClinicalTrials.gov