Eosinophilic EsophagitisEESYNCT04416217
Eosinophilic Esophagitis Steroid Safety Study
An observational study of Eosinophilic Esophagitis, run by Rabin Medical Center at 4 sites in 3 countries.
Trial summary
This observational study will follow pediatric patients with eosinophilic esophagitis who are scheduled to begin topical steroid treatment, from the initiation of treatment longitudinally to determine the safety profile of the drug. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Eosinophilic Esophagitis
- How many people
- 55 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 7 Oct 2019to 31 Dec 2024
- 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: Pediatric patients diagnosed with eosinophilic esophagitis for whom following discussion between the patient/gaurdians and physician treatment with topical steroids are planned.
Who may be able to join
- Age <18 years at the time of enrollment.
- Males and Females are included.
- Patients diagnosed with EoE as defined by age appropriate signs of esophageal dysfunction (in older children and adolescents - dysphagia, impacted food bolus, foreign body impaction, vomiting, and GERD not responsive to high dose proton pump inhibitors. In infants and young children - failure to thrive, poor feeding, vomiting, food bolus impaction)
- Histopathological finding of ≥15 eosinophils/high power field (X400) on at least one esophageal biopsy.
- After discussing the available treatment options with the gastroenterologist, the patient has chosen oral topical steroid treatment (either as a first treatment or after failure of other dietary or medical treatment).
Who cannot join
- Known alternative causes of esophageal eosinophilia.
- Legal guardian unable or unwilling to sign informed consent..
- Known allergy to topical steroids ingredients
- Patient will not be available for follow-up for at least the 3 month assessment and ACTH test.
- Known pregnancy
- Use of oral systemic steroids in the 6 months prior to inclusion in the study. Use of systemic steroids once in the study will not lead to study termination, but such use will need to be reported in the medication changes and use page of the following visit.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Italy2 sites
Department of Woman, Child and General and Specialized Surgery, University of the Campania "Luigi Vanvitelli"
Naples
Maternal and Child Health Department, Sapienza
Rome
Israel1 site
Institute of Gastroenterology, Nutrition and Liver Diseases; Schneider Children's Medical Center of Israel
Petah Tikva, 49202
About this study
Official title: Adrenal Suppression in Pediatric Eosinophilic Esophagitis Treated With Topical Steroids - A Multicenter, Prospective, Observational Safety Study
This observational study will follow pediatric patients with eosinophilic esophagitis who are scheduled to begin topical steroid treatment, from the initiation of treatment longitudinally to determine the safety profile of the drug.
- Conditions
- Eosinophilic Esophagitis
- Keywords
- Steroid , bone mineral density , DEXA , Adrenal
- Medical subject headings
- Eosinophilic Esophagitis
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 |
|---|---|---|
| Topical Steroid Treatment | Pediatric patients with eosinophilic esophagitis scheduled to begin topical steroid treatment for the treatment of their condition. The type of topical steroid is not limited and is at the discretion of the treating physician as are dosing and concomitant treatments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adrenal suppression
Rates of pathological adrenocorticotropic hormone (ACTH) tests at 3 and 12 months of topical steroid use
Measured: 3 months
Adrenal suppression
Rates of pathological adrenocorticotropic hormone (ACTH) tests at 3 and 12 months of topical steroid use
Measured: 12 months
Growth failure
Rates of decreased Height for age after 12 months of treatment.
Measured: 12 months
Growth failure
Rates of decreased Height for age after 12 months of treatment.
Measured: 36 months
Secondary outcomes (9)
Bone mineral density
Decrease in bone mineral density between first and second dual energy x-ray absorptiometry (DEXA)
Measured: 12 months
Bone mineral density
Decrease in bone mineral density between first and second dual energy x-ray absorptiometry (DEXA)
Measured: 3 years
Hyperglycemia
Rates of elevated fasting glucose after 3 and 12 months of treatment
Measured: 3 months
Hyperglycemia
Rates of elevated fasting glucose after 3 and 12 months of treatment
Measured: 12 months
Elevated Liver Enzymes
Elevated ALT
Measured: 3 months
Histological remission 3 months
Histological remission at endoscopy timepoints
Measured: 3 months
Histological remission 12 months
Histological remission at endoscopy timepoints
Measured: 12 months
Clinical remission
Clinical remission at endoscopy time points according to PEESS v.2
Measured: 3 months
Clinical remission
Clinical remission at endoscopy time points according to PEESS v.2
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start7 Oct 2019
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noam Zevit, Schneider Children's Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416217
- Sponsor's protocol ID
- 0521-19-RMC
- Acronym
- EESY
- Status last verified
- May 2025
- First submitted
- 24 May 2020
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lucendo AJ, Molina-Infante J, Arias A, von Arnim U, Bredenoord AJ, Bussmann C, Amil Dias J, Bove M, Gonzalez-Cervera J, Larsson H, Miehlke S, Papadopoulou A, Rodriguez-Sanchez J, Ravelli A, Ronkainen J, Santander C, Schoepfer AM, Storr MA, Terreehorst I, Straumann A, Attwood SE. Guidelines on eosinophilic esophagitis: evidence-based statements and recommendations for diagnosis and management in children and adults. United European Gastroenterol J. 2017 Apr;5(3):335-358. doi: 10.1177/2050640616689525. Epub 2017 Jan 23.
PubMed 28507746Hsu S, Wood C, Pan Z, Rahat H, Zeitler P, Fleischer D, Menard-Katcher C, Furuta GT, Atkins D. Adrenal Insufficiency in Pediatric Eosinophilic Esophagitis Patients Treated with Swallowed Topical Steroids. Pediatr Allergy Immunol Pulmonol. 2017 Sep 1;30(3):135-140. doi: 10.1089/ped.2017.0779.
PubMed 29062584Golekoh MC, Hornung LN, Mukkada VA, Khoury JC, Putnam PE, Backeljauw PF. Adrenal Insufficiency after Chronic Swallowed Glucocorticoid Therapy for Eosinophilic Esophagitis. J Pediatr. 2016 Mar;170:240-5. doi: 10.1016/j.jpeds.2015.11.026. Epub 2015 Dec 11.
PubMed 26687577Harel S, Hursh BE, Chan ES, Avinashi V, Panagiotopoulos C. Adrenal insufficiency exists for both swallowed budesonide and fluticasone propionate in the treatment of eosinophilic esophagitis. J Pediatr. 2016 Jul;174:281. doi: 10.1016/j.jpeds.2016.02.056. Epub 2016 Mar 19. No abstract available.
PubMed 27004676Philpott H, Dougherty MK, Reed CC, Caldwell M, Kirk D, Torpy DJ, Dellon ES. Systematic review: adrenal insufficiency secondary to swallowed topical corticosteroids in eosinophilic oesophagitis. Aliment Pharmacol Ther. 2018 Apr;47(8):1071-1078. doi: 10.1111/apt.14573. Epub 2018 Mar 5.
PubMed 29508432
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adrenal Suppression in Pediatric Eosinophilic Esophagitis Treated With Topical Steroids - A Multicenter, Prospective, Observational Safety Study
- ClinicalTrials.gov ID
- NCT04416217
- Acronym / sponsor ID
- EESY / 0521-19-RMC
- Conditions
- Eosinophilic Esophagitis
- Keywords
- Steroid , bone mineral density , DEXA , Adrenal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 4 Jun 2020 (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.
This observational study will follow pediatric patients with eosinophilic esophagitis who are scheduled to begin topical steroid treatment, from the initiation of treatment longitudinally to determine the safety profile of the drug.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Topical Steroid Treatment | – | –Pediatric patients with eosinophilic esophagitis scheduled to begin topical steroid treatment for the treatment of their condition. The type of topical steroid is not limited and is at the discretion of the treating physician as are dosing and concomitant treatments. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients diagnosed with eosinophilic esophagitis for whom following discussion between the patient/gaurdians and physician treatment with topical steroids are planned.
Key inclusion criteria (5 listed)
- Age <18 years at the time of enrollment.
- Males and Females are included.
- Patients diagnosed with EoE as defined by age appropriate signs of esophageal dysfunction (in older children and adolescents - dysphagia, impacted food bolus, foreign body impaction, vomiting, and GERD not responsive to high dose proton pump inhibitors. In infants and young children - failure to thrive, poor feeding, vomiting, food bolus impaction)
- Histopathological finding of ≥15 eosinophils/high power field (X400) on at least one esophageal biopsy.
- After discussing the available treatment options with the gastroenterologist, the patient has chosen oral topical steroid treatment (either as a first treatment or after failure of other dietary or medical treatment).
Key exclusion criteria (6 listed)
- Known alternative causes of esophageal eosinophilia.
- Legal guardian unable or unwilling to sign informed consent..
- Known allergy to topical steroids ingredients
- Patient will not be available for follow-up for at least the 3 month assessment and ACTH test.
- Known pregnancy
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
Adrenal suppression
Time frame: 3 months
Rates of pathological adrenocorticotropic hormone (ACTH) tests at 3 and 12 months of topical steroid use
Adrenal suppression
Time frame: 12 months
Rates of pathological adrenocorticotropic hormone (ACTH) tests at 3 and 12 months of topical steroid use
Growth failure
Time frame: 12 months
Rates of decreased Height for age after 12 months of treatment.
Growth failure
Time frame: 36 months
Rates of decreased Height for age after 12 months of treatment.
9 secondary outcomes
Bone mineral density
Time frame: 12 months
Bone mineral density
Time frame: 3 years
Hyperglycemia
Time frame: 3 months
Hyperglycemia
Time frame: 12 months
Elevated Liver Enzymes
Time frame: 3 months
Histological remission 3 months
Time frame: 3 months
Histological remission 12 months
Time frame: 12 months
Clinical remission
Time frame: 3 months
Clinical remission
Time frame: 12 months
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 7 May 2025.
- Background: PubMed 28507746Lucendo AJ, Molina-Infante J, Arias A, von Arnim U, Bredenoord AJ, Bussmann C, Amil Dias J, Bove M, Gonzalez-Cervera J, Larsson H, Miehlke S, Papadopoulou A, Rodriguez-Sanchez J, Ravelli A, Ronkainen J, Santander C, Schoepfer AM, Storr MA, Terreehorst I, Straumann A, Attwood SE. Guidelines on eosinophilic esophagitis: evidence-based statements and recommendations for diagnosis and management in children and adults. United European Gastroenterol J. 2017 Apr;5(3):335-358. doi: 10.1177/2050640616689525. Epub 2017 Jan 23.
- Background: PubMed 29062584Hsu S, Wood C, Pan Z, Rahat H, Zeitler P, Fleischer D, Menard-Katcher C, Furuta GT, Atkins D. Adrenal Insufficiency in Pediatric Eosinophilic Esophagitis Patients Treated with Swallowed Topical Steroids. Pediatr Allergy Immunol Pulmonol. 2017 Sep 1;30(3):135-140. doi: 10.1089/ped.2017.0779.
- Background: PubMed 26687577Golekoh MC, Hornung LN, Mukkada VA, Khoury JC, Putnam PE, Backeljauw PF. Adrenal Insufficiency after Chronic Swallowed Glucocorticoid Therapy for Eosinophilic Esophagitis. J Pediatr. 2016 Mar;170:240-5. doi: 10.1016/j.jpeds.2015.11.026. Epub 2015 Dec 11.
- Background: PubMed 27004676Harel S, Hursh BE, Chan ES, Avinashi V, Panagiotopoulos C. Adrenal insufficiency exists for both swallowed budesonide and fluticasone propionate in the treatment of eosinophilic esophagitis. J Pediatr. 2016 Jul;174:281. doi: 10.1016/j.jpeds.2016.02.056. Epub 2016 Mar 19. No abstract available.
- Background: PubMed 29508432Philpott H, Dougherty MK, Reed CC, Caldwell M, Kirk D, Torpy DJ, Dellon ES. Systematic review: adrenal insufficiency secondary to swallowed topical corticosteroids in eosinophilic oesophagitis. Aliment Pharmacol Ther. 2018 Apr;47(8):1071-1078. doi: 10.1111/apt.14573. Epub 2018 Mar 5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Esophagitis, run by Rabin Medical Center at 4 sites in 3 countries.
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 5 inclusion and 6 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 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy, Greece, Israel. 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?
Adrenal suppression (time frame: 3 months). The study lists 4 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 NCT04416217, which also lists 5 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 7 May 2025.