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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Eosinophilic Esophagitis
• Intervention / Treatment: Diagnostic test: High-resolution manometry; Diagnostic test: Serum biomarkers; Diagnostic test: Gastrointestinal Quality of Life index; Drug: Omeprazole 20 MG Oral Tablet

• Study Type: Observational
• Enrollment (Actual): 58

Contacts and Locations

Study Locations

• Poland
  • Borowska 213
    • Wrocław, Borowska 213, Poland, 50-556
      • Department of Gastroenterology and Hepatology, Wroclaw Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients hospitalized at the Department of Gastroenterology and Hepatology and the Department of Otolaryngology, Head and Neck Surgery at Wroclaw Medical University in Poland from 1.11.2017 to 31.12.2021 for endoscopic diagnosis of dysphagia.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	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.; Other Names: Omeprazole in the dose of 20 mg twice daily
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High-resolution manometry	The parameters of high-resolution esophageal manometry will be compared between EoE patients and controls.	3 months
Serum biomarkers	The serum levels of IL-5, IL-13, TGF-β1, MBP and eotaxin 3 will be compared between EoE patients and controls.	3 months
Gastrointestinal Quality of Life index	The Gastrointestinal Quality of Life index (GIQLI) will be compared between EoE patients and controls.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High-resolution manometry in the group of patients with EoE	The parameters of high-resolution esophageal manometry will be compared in the group of patients with EoE at enrollment in the project and after 3 months of treatment with PPIs.	3 months
Serum biomarkers in the group of patients with EoE	The 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.	3 months

Collaborators and Investigators

• Sponsor: Wroclaw Medical University
• Investigators: Principal Investigator: Dorota Waśko-Czopnik, PhD MD, Department of Gastroenterology and Hepatology, Wroclaw Medical University

Publications and helpful links

General Publications

• Sarbinowska J, Wiatrak B, Wasko-Czopnik D. Esophageal Motility Disorders in the Natural History of Acid-Dependent Causes of Dysphagia and Their Influence on Patients' Quality of Life-A Prospective Cohort Study. Int J Environ Res Public Health. 2021 Oct 23;18(21):11138. doi: 10.3390/ijerph182111138.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 14, 2017
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: March 14, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (ACTUAL): March 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: eosinophilic esophagitis; high-resolution manometry; eotaxin 3; major basic protein; interleukin 5; interleukin 13; transforming growth factor beta 1; Gastrointestinal Quality of Life index
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Immune System Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Gastrointestinal Diseases; Gastroenteritis; Hypersensitivity; Esophageal Diseases; Leukocyte Disorders; Eosinophilia; Inflammation; Eosinophilic Esophagitis; Esophagitis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Omeprazole
• Other Study ID Numbers: STM.C130.17.045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No