Eosinophilic EsophagitisNCT04803162
The Role of HRM and Specific Biomarkers of Inflammation in the Diagnosis of Patients With Dysphagia and Suspected EoE
An observational study of Eosinophilic Esophagitis, run by Wroclaw Medical University at 1 site in Poland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- High-resolution manometry, Serum biomarkers and Gastrointestinal Quality of Life index
- Type of treatment
- Pill or oral medicine
- How many people
- 58 participants
- Where
- 1 sitePoland
- Study dates
- 14 Nov 2017to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients over 18 years of age,
- patients referred for endoscopic diagnostics due to dysphagia.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Poland1 site
Department of Gastroenterology and Hepatology, Wroclaw Medical University
Wroclaw, Borowska 213, 50-556
About this study
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
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
- Being tested
- High-resolution manometry, Serum biomarkers, Gastrointestinal Quality of Life index, Omeprazole 20 MG Oral Tablet
- 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
- Medical subject headings
- Eosinophilic Esophagitis, Rhinitis, Allergic, Camurati-Engelmann Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-resolution manometryDiagnostic test
The parameters of high-resolution esophageal manometry will be compared between EoE patients and controls.
Serum biomarkersDiagnostic test
The 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 indexDiagnostic test
The Gastrointestinal Quality of Life index (GIQLI) will be compared between EoE patients and controls.
Omeprazole 20 MG Oral TabletDrug
Also called Omeprazole in the dose of 20 mg twice daily
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Diagnostic Test: High-resolution manometry; Diagnostic Test: Serum biomarkers; Diagnostic Test: Gastrointestinal Quality of Life index |
What is being measured
The primary outcome is the main question the study is designed to answer.
High-resolution manometry
The parameters of high-resolution esophageal manometry will be compared between EoE patients and controls.
Measured: 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.
Measured: 3 months
Gastrointestinal Quality of Life index
The Gastrointestinal Quality of Life index (GIQLI) will be compared between EoE patients and controls.
Measured: 3 months
Secondary outcomes (2)
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.
Measured: 3 months
Serum biomarkers in the group of patients with EoE
The 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start14 Nov 2017
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanna Sarbinowska, Wroclaw Medical University
- Investigators
- Dorota Waśko-Czopnik, PhD MD, Principal investigator, Department of Gastroenterology and Hepatology, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803162
- Sponsor's protocol ID
- STM.C130.17.045
- Status last verified
- Mar 2021
- First submitted
- 14 Mar 2021
- Last updated
- 17 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34769657
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04803162
- Acronym / sponsor ID
- STM.C130.17.045
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with eosinophilic esophagitis | – | Diagnostic Test: High-resolution manometry, Diagnostic Test: Serum biomarkers, Diagnostic Test: Gastrointestinal Quality of Life index, Drug: Omeprazole 20 MG Oral TabletEach 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). |
| patients without eosinophilic esophagitis | – | Diagnostic Test: High-resolution manometry, Diagnostic Test: Serum biomarkers, Diagnostic Test: Gastrointestinal Quality of Life indexEach 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- patients over 18 years of age,
- patients referred for endoscopic diagnostics due to dysphagia.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-resolution manometryThe parameters of high-resolution esophageal manometry will be compared between EoE patients and controls. | Diagnostic test | patients with eosinophilic esophagitis, patients without eosinophilic esophagitis |
| Serum biomarkersThe serum levels of IL-5, IL-13, TGF-β1, MBP and eotaxin 3 will be compared between EoE patients and controls. | Diagnostic test | patients with eosinophilic esophagitis, patients without eosinophilic esophagitis |
| Gastrointestinal Quality of Life indexThe Gastrointestinal Quality of Life index (GIQLI) will be compared between EoE patients and controls. | Diagnostic test | patients with eosinophilic esophagitis, patients without eosinophilic esophagitis |
| Omeprazole 20 MG Oral TabletAlso: Omeprazole in the dose of 20 mg twice dailyThe 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. | Drug | patients with eosinophilic esophagitis |
Primary outcome
High-resolution manometry
Time frame: 3 months
The parameters of high-resolution esophageal manometry will be compared between EoE patients and controls.
Serum biomarkers
Time frame: 3 months
The 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 index
Time frame: 3 months
The Gastrointestinal Quality of Life index (GIQLI) will be compared between EoE patients and controls.
2 secondary outcomes
High-resolution manometry in the group of patients with EoE
Time frame: 3 months
Serum biomarkers in the group of patients with EoE
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Derived from this study: PubMed 34769657Sarbinowska 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorota Waśko-Czopnik, PhD MD principal investigator
Department of Gastroenterology and Hepatology, Wroclaw Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Esophagitis, run by Wroclaw Medical University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High-resolution manometry (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04803162, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.