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

Wroclaw Medical University

Status: Unknown

Conditions: Eosinophilic Esophagitis

Treatments: Diagnostic Test: High-resolution manometry; Diagnostic Test: Gastrointestinal Quality of Life index; Diagnostic Test: Serum biomarkers; Drug: Omeprazole 20 MG Oral Tablet

Study type: Observational

Funder types: Other

Identifiers

NCT04803162

STM.C130.17.045

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

58 participants in 2 patient groups

patients with eosinophilic esophagitis

Description:

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).

Treatment:

Drug: Omeprazole 20 MG Oral Tablet

Diagnostic Test: High-resolution manometry

Diagnostic Test: Gastrointestinal Quality of Life index

Diagnostic Test: Serum biomarkers

patients without eosinophilic esophagitis

Description:

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.

Treatment:

Diagnostic Test: High-resolution manometry

Diagnostic Test: Gastrointestinal Quality of Life index

Diagnostic Test: Serum biomarkers