Eosinophilic EsophagitisNCT03069573
Phenotypic Characterization and Biomarkers Investigation for Eosinophilic Esophagitis in Pediatric Patients
An observational study of Eosinophilic Esophagitis and Gastroesophageal Reflux, run by Federal University of Uberlandia at 1 site in Brazil.
Trial summary
The purpose of this study is to find out some potential biomarkers for the Eosinophilic Esophagitis (EoE) in pediatric patients through the prospective clinical characterization and assessment of samples collected during the diagnostic process Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Eosinophilic Esophagitis, Gastroesophageal Reflux
- How many people
- 110 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2015to 30 Sep 2019
- How long will I take part?
- 2 Years
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Consecutive pediatric patients undergoing esophagogastroduodenoscopy (due to general complaints) at a Tertiary Public Health Care Center
Who may be able to join
- Pediatric patients who are undergoing upper gastrointestinal endoscopy for diagnostic purpose
Who cannot join
- Pediatric patients who are undergoing upper gastrointestinal endoscopy for therapeutic procedures
- The presence of other eosinophilic diseases
- Patients have been taken corticosteroids and/or gastric acid secretion inhibition drugs for the last four weeks
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Uberlandia
Uberlândia, Minas Gerais, 38400-902
About this study
Official title: Phenotypic Characterization of Pediatric Patients With Esophageal Eosinophilia and Biomarkers Investigation for the Diagnosis of Eosinophilic Esophagitis
The purpose of this study is to find out some potential biomarkers for the Eosinophilic Esophagitis (EoE) in pediatric patients through the prospective clinical characterization and assessment of samples collected during the diagnostic process
Read the detailed description
This study collects clinical information from pediatric patients between 0-18 years old who have been undergoing upper gastrointestinal endoscopy due to general complaints. The demographic, clinical symptoms, endoscopy, pH monitoring, and histology data are assessed during the diagnostic process. In the baseline endoscopy procedure samples (blood, saliva, esophageal tissue, and esophageal mucus) are taken. After diagnostic process of EoE and Gastroesophageal reflux disease (GERD) supported by International Guidelines the patients are divided into three groups - EoE, GERD, and Control.
The techniques are used for patients characterization and assessment:
- Symptoms score: General symptom score and/or Pediatric Eosinophilic Esophagitis Symptom Score (PEESS v2.0) - translated and adapted version for Brazilian Portuguese
- Endoscopic Score: Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS)
- Peak eosinophil count (PEC) and histological features description
- Proteomic analyses
- Microbiome analyses
- Immunohistochemistry analyses
- Conditions
- Eosinophilic Esophagitis, Gastroesophageal Reflux
- Keywords
- Eosinophilic Esophagitis, Gastroesophageal Reflux, Diagnose, Biomarker
- Medical subject headings
- Eosinophilic Esophagitis, Gastroesophageal Reflux, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Eosinophilic Esophagitis - EoE | Diagnosis of pediatric EoE under current guidelines. | |
| Gastroesophageal reflux disease - GERD | Diagnosis of pediatric GERD under current guidelines. | |
| Control | Exclusion diagnosis of EoE or GERD, with non specific gastrointestinal general complaints. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers for the diagnose of Pediatric Eosinophil Esophagitis
Identify diagnostic biomarker, able to distinguish EoE patients from GERD patients and other nonspecific gastrointestinal complains
Measured: 2016 August - 2017 March and 2018 November-December
Secondary outcomes (3)
Endoscopic features of EoE
Evaluation of the EREFS 'ability (endoscopic reference score) to identify EoE patients and the inflammatory or fibrosis phenotype
Measured: 2017 January-March and 2018 November-December
Symptoms of active EoE
Evaluation of the symptom score's ability to identify EoE patients in active disease
Measured: 2017 January-March and 2018 November-December
Histological features of EoE
Evaluation of the histologic score's ability to identify EoE patients and the inflammatory or fibrosis phenotype
Measured: 2017 January-March and 2018 November-December
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start1 Jan 2015
- Primary completion31 Aug 2016
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- 110 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Palmer Barros, Federal University of Uberlandia
- Investigators
- Luiz Ricardo Goulart, Professor, Study director, Federal University of UberlandiaCristina Palmer Barros, Professor, Principal investigator, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069573
- Sponsor's protocol ID
- CAAE-36787714.0.0000.5152
- Status last verified
- Sep 2020
- First submitted
- 19 Feb 2017
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Liacouras CA, Furuta GT, Hirano I, Atkins D, Attwood SE, Bonis PA, Burks AW, Chehade M, Collins MH, Dellon ES, Dohil R, Falk GW, Gonsalves N, Gupta SK, Katzka DA, Lucendo AJ, Markowitz JE, Noel RJ, Odze RD, Putnam PE, Richter JE, Romero Y, Ruchelli E, Sampson HA, Schoepfer A, Shaheen NJ, Sicherer SH, Spechler S, Spergel JM, Straumann A, Wershil BK, Rothenberg ME, Aceves SS. Eosinophilic esophagitis: updated consensus recommendations for children and adults. J Allergy Clin Immunol. 2011 Jul;128(1):3-20.e6; quiz 21-2. doi: 10.1016/j.jaci.2011.02.040. Epub 2011 Apr 7.
PubMed 21477849Vandenplas Y, Rudolph CD, Di Lorenzo C, Hassall E, Liptak G, Mazur L, Sondheimer J, Staiano A, Thomson M, Veereman-Wauters G, Wenzl TG, North American Society for Pediatric Gastroenterology Hepatology and Nutrition, European Society for Pediatric Gastroenterology Hepatology and Nutrition. Pediatric gastroesophageal reflux clinical practice guidelines: joint recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN). J Pediatr Gastroenterol Nutr. 2009 Oct;49(4):498-547. doi: 10.1097/MPG.0b013e3181b7f563.
PubMed 19745761Hirano I, Moy N, Heckman MG, Thomas CS, Gonsalves N, Achem SR. Endoscopic assessment of the oesophageal features of eosinophilic oesophagitis: validation of a novel classification and grading system. Gut. 2013 Apr;62(4):489-95. doi: 10.1136/gutjnl-2011-301817. Epub 2012 May 22.
PubMed 22619364Singla MB, Chehade M, Brizuela D, Maydonovitch CL, Chen YJ, Riffle ME, Achem SR, Moawad FJ. Early Comparison of Inflammatory vs. Fibrostenotic Phenotype in Eosinophilic Esophagitis in a Multicenter Longitudinal Study. Clin Transl Gastroenterol. 2015 Dec 17;6(12):e132. doi: 10.1038/ctg.2015.62.
PubMed 26680264Dohil R, Newbury R, Fox L, Bastian J, Aceves S. Oral viscous budesonide is effective in children with eosinophilic esophagitis in a randomized, placebo-controlled trial. Gastroenterology. 2010 Aug;139(2):418-29. doi: 10.1053/j.gastro.2010.05.001. Epub 2010 May 7.
PubMed 20457157Aceves SS, Newbury RO, Dohil MA, Bastian JF, Dohil R. A symptom scoring tool for identifying pediatric patients with eosinophilic esophagitis and correlating symptoms with inflammation. Ann Allergy Asthma Immunol. 2009 Nov;103(5):401-6. doi: 10.1016/S1081-1206(10)60359-6.
PubMed 19927538de Souza TA, Carneiro AP, Narciso AS, Barros CP, Alves DA, Marson LB, Tunala T, de Alcantara TM, de Paiva Maia YC, Briza P, Ferreira F, Goulart LR. Eosinophilic esophagitis auxiliary diagnosis based on a peptide ligand to eosinophil cationic protein in esophageal mucus of pediatric patients. Sci Rep. 2022 Jul 18;12(1):12226. doi: 10.1038/s41598-022-16293-1.
PubMed 35851408
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotypic Characterization of Pediatric Patients With Esophageal Eosinophilia and Biomarkers Investigation for the Diagnosis of Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT03069573
- Acronym / sponsor ID
- CAAE-36787714.0.0000.5152
- Conditions
- Eosinophilic Esophagitis, Gastroesophageal Reflux
- Keywords
- Eosinophilic Esophagitis, Gastroesophageal Reflux, Diagnose, Biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 3 Mar 2017 (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 purpose of this study is to find out some potential biomarkers for the Eosinophilic Esophagitis (EoE) in pediatric patients through the prospective clinical characterization and assessment of samples collected during the diagnostic process
Detailed description
This study collects clinical information from pediatric patients between 0-18 years old who have been undergoing upper gastrointestinal endoscopy due to general complaints. The demographic, clinical symptoms, endoscopy, pH monitoring, and histology data are assessed during the diagnostic process. In the baseline endoscopy procedure samples (blood, saliva, esophageal tissue, and esophageal mucus) are taken. After diagnostic process of EoE and Gastroesophageal reflux disease (GERD) supported by International Guidelines the patients are divided into three groups - EoE, GERD, and Control.
The techniques are used for patients characterization and assessment:
- Symptoms score: General symptom score and/or Pediatric Eosinophilic Esophagitis Symptom Score (PEESS v2.0) - translated and adapted version for Brazilian Portuguese
- Endoscopic Score: Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS)
- Peak eosinophil count (PEC) and histological features description
- Proteomic analyses
- Microbiome analyses
- Immunohistochemistry analyses
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eosinophilic Esophagitis - EoE | – | –Diagnosis of pediatric EoE under current guidelines. |
| Gastroesophageal reflux disease - GERD | – | –Diagnosis of pediatric GERD under current guidelines. |
| Control | – | –Exclusion diagnosis of EoE or GERD, with non specific gastrointestinal general complaints. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Consecutive pediatric patients undergoing esophagogastroduodenoscopy (due to general complaints) at a Tertiary Public Health Care Center
Key inclusion criteria (1 listed)
- Pediatric patients who are undergoing upper gastrointestinal endoscopy for diagnostic purpose
Key exclusion criteria (3 listed)
- Pediatric patients who are undergoing upper gastrointestinal endoscopy for therapeutic procedures
- The presence of other eosinophilic diseases
- Patients have been taken corticosteroids and/or gastric acid secretion inhibition drugs for the last four weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biomarkers for the diagnose of Pediatric Eosinophil Esophagitis
Time frame: 2016 August - 2017 March and 2018 November-December
Identify diagnostic biomarker, able to distinguish EoE patients from GERD patients and other nonspecific gastrointestinal complains
3 secondary outcomes
Endoscopic features of EoE
Time frame: 2017 January-March and 2018 November-December
Symptoms of active EoE
Time frame: 2017 January-March and 2018 November-December
Histological features of EoE
Time frame: 2017 January-March and 2018 November-December
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Background: PubMed 21477849Liacouras CA, Furuta GT, Hirano I, Atkins D, Attwood SE, Bonis PA, Burks AW, Chehade M, Collins MH, Dellon ES, Dohil R, Falk GW, Gonsalves N, Gupta SK, Katzka DA, Lucendo AJ, Markowitz JE, Noel RJ, Odze RD, Putnam PE, Richter JE, Romero Y, Ruchelli E, Sampson HA, Schoepfer A, Shaheen NJ, Sicherer SH, Spechler S, Spergel JM, Straumann A, Wershil BK, Rothenberg ME, Aceves SS. Eosinophilic esophagitis: updated consensus recommendations for children and adults. J Allergy Clin Immunol. 2011 Jul;128(1):3-20.e6; quiz 21-2. doi: 10.1016/j.jaci.2011.02.040. Epub 2011 Apr 7.
- Background: PubMed 19745761Vandenplas Y, Rudolph CD, Di Lorenzo C, Hassall E, Liptak G, Mazur L, Sondheimer J, Staiano A, Thomson M, Veereman-Wauters G, Wenzl TG, North American Society for Pediatric Gastroenterology Hepatology and Nutrition, European Society for Pediatric Gastroenterology Hepatology and Nutrition. Pediatric gastroesophageal reflux clinical practice guidelines: joint recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN). J Pediatr Gastroenterol Nutr. 2009 Oct;49(4):498-547. doi: 10.1097/MPG.0b013e3181b7f563.
- Background: PubMed 22619364Hirano I, Moy N, Heckman MG, Thomas CS, Gonsalves N, Achem SR. Endoscopic assessment of the oesophageal features of eosinophilic oesophagitis: validation of a novel classification and grading system. Gut. 2013 Apr;62(4):489-95. doi: 10.1136/gutjnl-2011-301817. Epub 2012 May 22.
- Background: PubMed 26680264Singla MB, Chehade M, Brizuela D, Maydonovitch CL, Chen YJ, Riffle ME, Achem SR, Moawad FJ. Early Comparison of Inflammatory vs. Fibrostenotic Phenotype in Eosinophilic Esophagitis in a Multicenter Longitudinal Study. Clin Transl Gastroenterol. 2015 Dec 17;6(12):e132. doi: 10.1038/ctg.2015.62.
- Background: PubMed 20457157Dohil R, Newbury R, Fox L, Bastian J, Aceves S. Oral viscous budesonide is effective in children with eosinophilic esophagitis in a randomized, placebo-controlled trial. Gastroenterology. 2010 Aug;139(2):418-29. doi: 10.1053/j.gastro.2010.05.001. Epub 2010 May 7.
- Background: PubMed 19927538Aceves SS, Newbury RO, Dohil MA, Bastian JF, Dohil R. A symptom scoring tool for identifying pediatric patients with eosinophilic esophagitis and correlating symptoms with inflammation. Ann Allergy Asthma Immunol. 2009 Nov;103(5):401-6. doi: 10.1016/S1081-1206(10)60359-6.
- Derived from this study: PubMed 35851408de Souza TA, Carneiro AP, Narciso AS, Barros CP, Alves DA, Marson LB, Tunala T, de Alcantara TM, de Paiva Maia YC, Briza P, Ferreira F, Goulart LR. Eosinophilic esophagitis auxiliary diagnosis based on a peptide ligand to eosinophil cationic protein in esophageal mucus of pediatric patients. Sci Rep. 2022 Jul 18;12(1):12226. doi: 10.1038/s41598-022-16293-1.
- 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.
Luiz Ricardo Goulart, Professor study director
Federal University of Uberlandia
Cristina Palmer Barros, Professor principal investigator
Federal University of Uberlandia
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 and Gastroesophageal Reflux, run by Federal University of Uberlandia at 1 site in Brazil.
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 1 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: finished, as of the sponsor's last update on 1 Oct 2020. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Biomarkers for the diagnose of Pediatric Eosinophil Esophagitis (time frame: 2016 August - 2017 March and 2018 November-December). 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 NCT03069573, which also lists 7 linked publications.
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 1 Oct 2020.