NCT04803162

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

The Role of High-resolution Esophageal Manometry and Specific Biomarkers of Inflammation in the Diagnosis of Patients With Dysphagia and Suspected Eosinophilic Esophagitis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 58 (actual)
• Sponsor: Wroclaw Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Eosinophilic Esophagitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-11-14
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2021-03-17
• Last updated: 2021-03-17

Locations

1 site across 1 country: Poland