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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04803162
Recruitment Status : Active, not recruiting
First Posted : March 17, 2021
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
Joanna Sarbinowska, Wroclaw Medical University

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

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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


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 Name: 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.




Primary Outcome Measures :
  1. High-resolution manometry [ Time Frame: 3 months ]
    The parameters of high-resolution esophageal manometry will be compared between EoE patients and controls.

  2. 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.

  3. 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 :
  1. 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.

  2. 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


Information from the National Library of Medicine

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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
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Poland
Department of Gastroenterology and Hepatology, Wroclaw Medical University
Wrocław, Borowska 213, Poland, 50-556
Sponsors and Collaborators
Wroclaw Medical University
Investigators
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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):
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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

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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:
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