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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04803162
Enrollment
58
Registered
2021-03-17
Start date
2017-11-14
Completion date
2021-12-31
Last updated
2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

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

DIAGNOSTIC_TESTSerum biomarkers

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

DIAGNOSTIC_TESTGastrointestinal Quality of Life index

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

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.

Sponsors

Wroclaw Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
High-resolution manometry3 monthsThe parameters of high-resolution esophageal manometry will be compared between EoE patients and controls.
Serum biomarkers3 monthsThe serum levels of IL-5, IL-13, TGF-β1, MBP and eotaxin 3 will be compared between EoE patients and controls.
Gastrointestinal Quality of Life index3 monthsThe Gastrointestinal Quality of Life index (GIQLI) will be compared between EoE patients and controls.

Secondary

MeasureTime frameDescription
High-resolution manometry in the group of patients with EoE3 monthsThe 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.
Serum biomarkers in the group of patients with EoE3 monthsThe 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.

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026