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

NCT04803162 | Unknown

• 1 other identifier: STM.C130.17.045
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Eosinophilic Esophagitis

Keywords

eosinophilic esophagitis; eotaxin 3; major basic protein; interleukin 5; interleukin 13; transforming growth factor beta 1; high-resolution manometry; Gastrointestinal Quality of Life index

Outcome Measures

Primary Outcomes (3)

• High-resolution manometry

  The parameters of high-resolution esophageal manometry will be compared between EoE patients and controls.

  3 months

• Serum biomarkers

  The serum levels of IL-5, IL-13, TGF-β1, MBP and eotaxin 3 will be compared between EoE patients and controls.

  3 months

• Gastrointestinal Quality of Life index

  The Gastrointestinal Quality of Life index (GIQLI) will be compared between EoE patients and controls.

  3 months

Secondary Outcomes (2)

• High-resolution manometry in the group of patients with EoE

  3 months

• Serum biomarkers in the group of patients with EoE

  3 months

Study Arms (2)

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; Diagnostic Test: Serum biomarkers; Diagnostic Test: Gastrointestinal Quality of Life index; Drug: Omeprazole 20 MG Oral Tablet

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; Diagnostic Test: Serum biomarkers; Diagnostic Test: Gastrointestinal Quality of Life index

Interventions

High-resolution manometry DIAGNOSTIC_TEST

The parameters of high-resolution esophageal manometry will be compared between EoE patients and controls.

patients with eosinophilic esophagitis; patients without eosinophilic esophagitis

Serum biomarkers DIAGNOSTIC_TEST

The serum levels of IL-5, IL-13, TGF-β1, MBP and eotaxin 3 will be compared between EoE patients and controls.

patients with eosinophilic esophagitis; patients without eosinophilic esophagitis

Gastrointestinal Quality of Life index DIAGNOSTIC_TEST

The Gastrointestinal Quality of Life index (GIQLI) will be compared between EoE patients and controls.

patients with eosinophilic esophagitis; patients without eosinophilic esophagitis

Omeprazole 20 MG Oral Tablet DRUG

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.

Also known as: Omeprazole in the dose of 20 mg twice daily

patients with eosinophilic esophagitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• patients over 18 years of age,
• patients referred for endoscopic diagnostics due to dysphagia.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

Department of Gastroenterology and Hepatology, Wroclaw Medical University

Wroclaw, Borowska 213, 50-556, Poland

Location

Related Publications (1)

• Sarbinowska J, Wiatrak B, Wasko-Czopnik D. Esophageal Motility Disorders in the Natural History of Acid-Dependent Causes of Dysphagia and Their Influence on Patients' Quality of Life-A Prospective Cohort Study. Int J Environ Res Public Health. 2021 Oct 23;18(21):11138. doi: 10.3390/ijerph182111138.

  PMID: 34769657 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

fixed tissue, serum

MeSH Terms

Conditions

Eosinophilic Esophagitis; Rhinitis, Allergic; Camurati-Engelmann Syndrome

Interventions

Omeprazole; Tablets

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Dorota Waśko-Czopnik, PhD MD

  Department of Gastroenterology and Hepatology, Wroclaw Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 14, 2021
• First Posted: March 17, 2021
• Study Start: November 14, 2017
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)