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

Study Overview
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Brief Summary
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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.

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

Conditions
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Eosinophilic Esophagitis

Intervention / Treatment
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* Diagnostic Test: High-resolution manometry
* Diagnostic Test: Serum biomarkers
* Diagnostic Test: Gastrointestinal Quality of Life index
* Drug: Omeprazole 20 MG Oral Tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with eosinophilic esophagitis<br>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). | Drug: Omeprazole 20 MG Oral Tablet<br>* 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.<br>* Other names: Omeprazole in the dose of 20 mg twice daily;Diagnostic Test: High-resolution manometry<br>* The parameters of high-resolution esophageal manometry will be compared between EoE patients and controls.<br>Diagnostic Test: Serum biomarkers<br>* The serum levels of IL-5, IL-13, TGF-β1, MBP and eotaxin 3 will be compared between EoE patients and controls.<br>Diagnostic Test: Gastrointestinal Quality of Life index<br>* The Gastrointestinal Quality of Life index (GIQLI) will be compared between EoE patients and controls.<br>|
| patients without eosinophilic esophagitis<br>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: Gastrointestinal Quality of Life index<br>* The Gastrointestinal Quality of Life index (GIQLI) will be compared between EoE patients and controls.<br>Diagnostic Test: High-resolution manometry<br>* The parameters of high-resolution esophageal manometry will be compared between EoE patients and controls.<br>Diagnostic Test: Serum biomarkers<br>* The serum levels of IL-5, IL-13, TGF-β1, MBP and eotaxin 3 will be compared between EoE patients and controls.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eosinophilic esophagitis, eotaxin 3, major basic protein, interleukin 5, interleukin 13, transforming growth factor beta 1, high-resolution manometry, Gastrointestinal Quality of Life index