The Role of HRM and Specific Biomarkers of Inflammation in the Diagnosis of Patients With Dysphagia and Suspected EoE
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| ClinicalTrials.gov Identifier: NCT04803162 |
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Recruitment Status :
Active, not recruiting
First Posted : March 17, 2021
Last Update Posted : March 17, 2021
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Sponsor:
Wroclaw Medical University
Information provided by (Responsible Party):
Joanna Sarbinowska, Wroclaw Medical University
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Brief 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.
| Condition or disease | Intervention/treatment |
|---|---|
| Eosinophilic Esophagitis | 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 |
| Actual Enrollment : | 58 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | The Role of High-resolution Esophageal Manometry and Specific Biomarkers of Inflammation in the Diagnosis of Patients With Dysphagia and Suspected Eosinophilic Esophagitis |
| Actual Study Start Date : | November 14, 2017 |
| Estimated Primary Completion Date : | December 2021 |
| Estimated Study Completion Date : | December 2021 |
Resource links provided by the National Library of Medicine
| Group/Cohort | Intervention/treatment |
|---|---|
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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).
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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 Name: Omeprazole in the dose of 20 mg twice daily |
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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.
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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. |
Primary Outcome Measures :
- High-resolution manometry [ Time Frame: 3 months ]The parameters of high-resolution esophageal manometry will be compared between EoE patients and controls.
- Serum biomarkers [ Time Frame: 3 months ]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 [ Time Frame: 3 months ]The Gastrointestinal Quality of Life index (GIQLI) will be compared between EoE patients and controls.
Secondary Outcome Measures :
- High-resolution manometry in the group of patients with EoE [ Time Frame: 3 months ]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.
- Serum biomarkers in the group of patients with EoE [ Time Frame: 3 months ]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.
Biospecimen Retention: Samples Without DNA
fixed tissue, serum
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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.
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04803162
Locations
| Poland | |
| Department of Gastroenterology and Hepatology, Wroclaw Medical University | |
| Wrocław, Borowska 213, Poland, 50-556 | |
Sponsors and Collaborators
Wroclaw Medical University
Investigators
| Principal Investigator: | Dorota Waśko-Czopnik, PhD MD | Department of Gastroenterology and Hepatology, Wroclaw Medical University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Joanna Sarbinowska, MD, Wroclaw Medical University |
| ClinicalTrials.gov Identifier: | NCT04803162 |
| Other Study ID Numbers: |
STM.C130.17.045 |
| First Posted: | March 17, 2021 Key Record Dates |
| Last Update Posted: | March 17, 2021 |
| Last Verified: | March 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Joanna Sarbinowska, Wroclaw Medical University:
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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 |
Additional relevant MeSH terms:
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Esophagitis Eosinophilic Esophagitis Inflammation Pathologic Processes Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis Eosinophilia Leukocyte Disorders |
Hematologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Omeprazole Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |