Eosinophilic EsophagitisRENESENCT03858426
Prospective Multicenter Nationwide Registry of Children With Eosinophilic Esophagitis
An observational study of Eosinophilic Esophagitis, run by Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica at 1 site in Spain.
Trial summary
1. Registry of demographic, clinical, endoscopic and histological data at baseline. 2. Registry of patients treated with PPI: Clinical, endoscopic and histological response at 8-12 weeks of induction treatment Clinical, endoscopic and histological response at 6 and 12 months weeks of maintenance treatment 3. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Eosinophilic Esophagitis
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2019to 30 Jul 2022
- 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 1 month to 18 years
- All sexes
- Child, Adult
Study population: Children from 1 month to 18 years with a new diagnosis of eosinophilic esophagitis according to the recent European guidelines
Who may be able to join
- Children from 1 month to 18 years with a new diagnosis of eosinophilic esophagitis (EoE) according to the recent European guidelines (symptoms of esophageal dysfunction + eosinophilic infiltrate of the esophagus > 15 eos / CGA)
- And that they need to start treatment with any of the following options: PPI, diet excluding cow's milk and gluten, or swallowed corticosteroids .
Who cannot join
- Presence of pathological eosinophilia at the gastric or duodenal level (eosinophilic gastroenteritis)
- Simultaneous treatment with more than one treatment modality (PPI, empirical elimination diet, swallowed corticosteroids).
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, 28222
Carolina Gutierrez Junquera, PhD, 911916437, carolina.gutijun@salud.madrid.org
About this study
- Registry of demographic, clinical, endoscopic and histological data at baseline.
- Registry of patients treated with PPI:
- Clinical, endoscopic and histological response at 8-12 weeks of induction treatment
- Clinical, endoscopic and histological response at 6 and 12 months weeks of maintenance treatment
Read more
- Registry of patients treated with two foods elimination diet:
- Clinical, endoscopic and histological response at 8-12 weeks of induction treatment
- Identification of food trigger: milk, gluten or milk and gluten
- Clinical, endoscopic and histological response at one year elimination of food trigger
- Registry of adverse events
- Registry of patients treated with swallowed steroids (budesonide or fluticasone):
- Clinical, endoscopic and histological response at 8-12 weeks of induction treatment
- Clinical, endoscopic and histological response at 6 months of maintenance steroid treatment
- Registry of adverse events
- Conditions
- Eosinophilic Esophagitis
- Being tested
- no intervention
- Keywords
- Eosinophilic Esophagitis; PPIs, children, elimination diet, topical steroids
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Children with eosinophilic esophagitis | Inclusion criteria:
* Children from 1 month to 18 years with a new diagnosis of eosinophilic esophagitis according to recent European guidelines (symptoms of esophageal dysfunction + eosinophilic infiltrate of the esophagus > 15 eos / CGA)
* And they need to start treatment with one of the following options: PPI, diet excluding cow's milk and gluten, or swallowed corticosteroids
Exclusion criteria:
* Presence of pathological eosinophilia at the gastric or duodenal level (eosinophilic gastroenteritis)
* Simultaneous treatment with more than one treatment modality (PPI, empirical elimination diet, swallowed corticosteroids). Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete histological remission
Complete histological remission response defined as ≤5 eosinophils/hpf in all biopsies performed
Measured: 12 weeks
Secondary outcomes (2)
Partial histological remission
Partial histological remission response defined as 5-15 eosinophils /hpf in all biopsies
Measured: 12 weeks
Clinical remission
Clinical remission (specific questionnaire)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start1 Jan 2019
- Primary completion1 Nov 2020 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolina Gutierrez Junquera, Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858426
- Sponsor's protocol ID
- RENESE
- Acronym
- RENESE
- Status last verified
- Feb 2019
- First submitted
- 11 Oct 2018
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Nationwide Registry of Children With Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT03858426
- Acronym / sponsor ID
- RENESE / RENESE
- Conditions
- Eosinophilic Esophagitis
- Keywords
- Eosinophilic Esophagitis; PPIs, children, elimination diet, topical steroids
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion PediatricaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 28 Feb 2019 (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.
- Registry of demographic, clinical, endoscopic and histological data at baseline.
- Registry of patients treated with PPI:
- Clinical, endoscopic and histological response at 8-12 weeks of induction treatment
- Clinical, endoscopic and histological response at 6 and 12 months weeks of maintenance treatment
- Registry of patients treated with two foods elimination diet:
- Clinical, endoscopic and histological response at 8-12 weeks of induction treatment
- Identification of food trigger: milk, gluten or milk and gluten
- Clinical, endoscopic and histological response at one year elimination of food trigger
- Registry of adverse events
- Registry of patients treated with swallowed steroids (budesonide or fluticasone):
- Clinical, endoscopic and histological response at 8-12 weeks of induction treatment
- Clinical, endoscopic and histological response at 6 months of maintenance steroid treatment
- Registry of adverse events
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with eosinophilic esophagitis | – | Other: no interventionInclusion criteria: * Children from 1 month to 18 years with a new diagnosis of eosinophilic esophagitis according to recent European guidelines (symptoms of esophageal dysfunction + eosinophilic infiltrate of the esophagus > 15 eos / CGA) * And they need to start treatment with one of the following options: PPI, diet excluding cow's milk and gluten, or swallowed corticosteroids Exclusion criteria: * Presence of pathological eosinophilia at the gastric or duodenal level (eosinophilic gastroenteritis) * Simultaneous treatment with more than one treatment modality (PPI, empirical elimination diet, swallowed corticosteroids). |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children from 1 month to 18 years with a new diagnosis of eosinophilic esophagitis according to the recent European guidelines
Key inclusion criteria (2 listed)
- Children from 1 month to 18 years with a new diagnosis of eosinophilic esophagitis (EoE) according to the recent European guidelines (symptoms of esophageal dysfunction + eosinophilic infiltrate of the esophagus > 15 eos / CGA)
- And that they need to start treatment with any of the following options: PPI, diet excluding cow's milk and gluten, or swallowed corticosteroids .
Key exclusion criteria (2 listed)
- Presence of pathological eosinophilia at the gastric or duodenal level (eosinophilic gastroenteritis)
- Simultaneous treatment with more than one treatment modality (PPI, empirical elimination diet, swallowed corticosteroids).
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 |
|---|---|---|
| no interventionno intervention | Other | Children with eosinophilic esophagitis |
Primary outcome
Complete histological remission
Time frame: 12 weeks
Complete histological remission response defined as ≤5 eosinophils/hpf in all biopsies performed
2 secondary outcomes
Partial histological remission
Time frame: 12 weeks
Clinical remission
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
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 Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica at 1 site in Spain.
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 2 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 28 Feb 2019. 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 Spain. 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?
Contact Carolina Gutierrez-Junquera, MD, PHD (+34911916437, carolina.gutijun@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete histological remission (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2019.