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

Eosinophilic Esophagitis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04803162
• Other study ID #: STM.C130.17.045
• Status: Active, not recruiting
• Start date: November 14, 2017
• Est. completion date: December 2021

Study information

• Verified date: March 2021
• Source: Wroclaw Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis
• Inflammation

Intervention

Diagnostic Test:
• 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-ß1, 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.

Drug:
• Omeprazole 20 MG Oral Tablet
The parameters of high-resolution esophageal manometry and serum levels of IL-5, IL-13, TGF-ß1, 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.

Locations

Country	Name	City	State
Poland	Department of Gastroenterology and Hepatology, Wroclaw Medical University	Wroclaw	Borowska 213

Sponsors (1)

Lead Sponsor	Collaborator
Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High-resolution manometry	The parameters of high-resolution esophageal manometry will be compared between EoE patients and controls.	3 months
Primary	Serum biomarkers	The serum levels of IL-5, IL-13, TGF-ß1, MBP and eotaxin 3 will be compared between EoE patients and controls.	3 months
Primary	Gastrointestinal Quality of Life index	The Gastrointestinal Quality of Life index (GIQLI) will be compared between EoE patients and controls.	3 months
Secondary	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
Secondary	Serum biomarkers in the group of patients with EoE	The serum levels of IL-5, IL-13, TGF-ß1, 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