The Role of HRM and Specific Biomarkers of Inflammation in the Diagnosis of Patients With Dysphagia and Suspected EoE
NCT ID: NCT04803162
Last Updated: 2021-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
58 participants
OBSERVATIONAL
2017-11-14
2021-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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).
High-resolution manometry
The parameters of high-resolution esophageal manometry will be compared between EoE patients and controls.
Serum biomarkers
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
The Gastrointestinal Quality of Life index (GIQLI) will be compared between EoE patients and controls.
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.
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.
High-resolution manometry
The parameters of high-resolution esophageal manometry will be compared between EoE patients and controls.
Serum biomarkers
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
The Gastrointestinal Quality of Life index (GIQLI) will be compared between EoE patients and controls.
Interventions
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High-resolution manometry
The parameters of high-resolution esophageal manometry will be compared between EoE patients and controls.
Serum biomarkers
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
The Gastrointestinal Quality of Life index (GIQLI) will be compared between EoE patients and controls.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patients referred for endoscopic diagnostics due to dysphagia.
Exclusion Criteria
* rheumatological, dermatological and genetic disorders with possible peripheral eosinophilia,
* dysphagia caused by a diagnosed neoplastic infiltration of the esophagus.
18 Years
ALL
No
Sponsors
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Wroclaw Medical University
OTHER
Responsible Party
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Joanna Sarbinowska
MD
Principal Investigators
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Dorota Waśko-Czopnik, PhD MD
Role: PRINCIPAL_INVESTIGATOR
Department of Gastroenterology and Hepatology, Wroclaw Medical University
Locations
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Department of Gastroenterology and Hepatology, Wroclaw Medical University
Wroclaw, Borowska 213, Poland
Countries
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References
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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.
Other Identifiers
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STM.C130.17.045
Identifier Type: -
Identifier Source: org_study_id
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