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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-resolution manometry | Diagnostic Test | The parameters of high-resolution esophageal manometry will be compared between EoE patients and controls. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Dorota Waśko-Czopnik, PhD MD | Department of Gastroenterology and Hepatology, Wroclaw Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology and Hepatology, Wroclaw Medical University | Wroclaw | Borowska 213 | 50-556 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34769657 | Derived | 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. |
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fixed tissue, serum
| 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. |
|
|
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 |
| ID | Term |
|---|---|
| D057765 | Eosinophilic Esophagitis |
| D065631 | Rhinitis, Allergic |
| D003966 | Camurati-Engelmann Syndrome |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D010009 | Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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