Esophagitis, EosinophilicObs-OENCT06190080
Outcome of Children With Eosinophilic Esophagitis
A study testing Digestive endoscopy in people with Esophagitis, Eosinophilic, run by Fondation Lenval at 1 site in France.
Trial summary
The investigator would like to create a prospective cohort of patients in order to describe eosinophilic esophagitis with the specificities corresponding to our geographical territory, and to study their evolution at 3 months, 6 months, 12 months, 18 months and 24 months. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Esophagitis, Eosinophilic
- What is being tested?
- Digestive endoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2024to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of OE according to the diagnostic criteria of the PNDS published in July 2022
- Due to start treatment.
- informed consent from one of the 2 parents or the representative of parental authority.
- Membership of a social security scheme.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marion Mouchet contact
France1 site
Hôpitaux pédiatriques de Nice CHU Lenval
Nice, 06200
Mathilde Butori Pepino, MD, 04.92.03.10.12, mathilde.butori@hpu.lenval.com
Marion Mouchet, marion6.mouchet@orange.fr
About this study
Official title: Outcomes of Children With Eosinophilic Esophagitis: a Prospective Monocentric Observational Study
The investigator would like to create a prospective cohort of patients in order to describe eosinophilic esophagitis with the specificities corresponding to our geographical territory, and to study their evolution at 3 months, 6 months, 12 months, 18 months and 24 months.
This study would also enable us to investigate the quality of life of these chronically ill patients
Read the detailed description
The investigator would like to create a prospective cohort of 16 patients included over 2 years in order to determine the rate of complete remission (clinical, endoscopic and histological) at 3 months, 6 months, 12 months, 18 months and 24 months of treatment initiation. It is also planned to describe this cohort of pediatric EO patients at inclusion and throughout follow-up, and to study their quality of life.
Follow-up visits is organized every 3 months with a gastropediatrician, who assesses the patient's symptoms (PEESS score) and quality of life (PedsQL eosinophilic esophagitis module and PedsQL 4.0 Generic Core Scales).
If treatment needs to be introduced or changed, a digestive endoscopy with biopsies will be carried out at 3 months to determine whether the patient is in remission or not.
- Conditions
- Esophagitis, Eosinophilic
- Being tested
- Digestive endoscopy
- Keywords
- children, eosinophilic esophagitis, life quality
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digestive endoscopyOther
Digestive endoscopies are performed in the operative room under general anaesthetic 3 months after the introduction or change of treatment. Biopsies of the upper, middle and lower thirds of the esophagus will be taken and analyzed for pathology.
| Study group | Role | What they receive |
|---|---|---|
| Management of eosinophilic esophagitis | Other | Follow-up visits are always organized in the same way. A consultation with a gastropediatrician will take place, with assessment of symptoms (PEESS score) and quality of life (PedsQL module for eosinophilic esophagitis and PedsQL 4.0 Generic Core Scales). Then, if treatment needs to be introduced or changed, a digestive endoscopy with biopsies will be carried out at 3 months to determine whether the patient is in remission or not. Depending on the results, the patient may be advised to adapt or maintain the current treatment. Receives: Other: Digestive endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the rate of complete remission
Complete remission will be defined according to the following criteria:
- Abolition of clinical symptoms as assessed by the Pediatric Eosinophilic Esophagitis Symptom Score
- Endoscopic score: EoE Endoscopic Reference Score (EREFS) ≤ 2 in the lower, middle and upper thirds of the esophagus.
- Eosinophilic infiltrate < 5/HPF in standard HES (Haemato-Eosin-Safran) stain on biopsies from lower, middle and upper thirds of esophagus
- No therapeutic change at follow-up visit to assess remission
Measured: at 3 months, 6 months, 12 months, 18 months and 24 months from treatment initiation.
Secondary outcomes (2)
Description at inclusion of a cohort of pediatric patients with OE
The description of the population will be carried out at baseline and during a 24 months follow-up at each consultation (M3, M6, M12, M18 and M24) by the patient's referring physician, listing :
- demographic (age, gender, lifestyle) and medical (history, allergies, etc.) data at baseline only
- Clinical data (types of symptoms, possible complications, etc.)
- Paraclinical data (endoscopic and anapathic scores at diagnosis)
Measured: throught a 24 months follow-up
evolution of quality of life
Quality of life will be measured using the Pediatric Quality of Life Questionnaire (PedsQL Eosinophilic Esophagitis part ) currently being validated in French by our team.
The PedsQL eosinophilic eosophagitis module is divided into several forms, each corresponding to different age groups with questions adapted according to age. (2-4 years, 5-7 years, 8-12 years and 13-18 years). This questionnaire is intended for children and their parents.
The total score is the sum of the 35 items for 8-17 year olds, 22 for 2-4 year olds, 27 for 5-7 year olds. The maximum score is 175 for 8-17 year olds, 110 for 2-4 year olds, 135 for 5-7 year olds. The higher the score, the greater the impact of eosinophilic esophagitis on the patient's life.
Nevertheless, we will also use a more general quality-of-life questionnaire, the PedsQL 4.0 Generic Core Scales in its French version.
Measured: at diagnosis, 3 months, 6 months, 12 months, 18 months and 24 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study startMar 2024 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagitis, EosinophilicStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190080
- Sponsor's protocol ID
- 23-HPNCL-05
- Acronym
- Obs-OE
- Status last verified
- Dec 2023
- First submitted
- 19 Dec 2023
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Children With Eosinophilic Esophagitis: a Prospective Monocentric Observational Study
- ClinicalTrials.gov ID
- NCT06190080
- Acronym / sponsor ID
- Obs-OE / 23-HPNCL-05
- Conditions
- Esophagitis, Eosinophilic
- Keywords
- children, eosinophilic esophagitis, life quality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 5 Jan 2024 (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 investigator would like to create a prospective cohort of patients in order to describe eosinophilic esophagitis with the specificities corresponding to our geographical territory, and to study their evolution at 3 months, 6 months, 12 months, 18 months and 24 months.
This study would also enable us to investigate the quality of life of these chronically ill patients
Detailed description
The investigator would like to create a prospective cohort of 16 patients included over 2 years in order to determine the rate of complete remission (clinical, endoscopic and histological) at 3 months, 6 months, 12 months, 18 months and 24 months of treatment initiation. It is also planned to describe this cohort of pediatric EO patients at inclusion and throughout follow-up, and to study their quality of life.
Follow-up visits is organized every 3 months with a gastropediatrician, who assesses the patient's symptoms (PEESS score) and quality of life (PedsQL eosinophilic esophagitis module and PedsQL 4.0 Generic Core Scales).
If treatment needs to be introduced or changed, a digestive endoscopy with biopsies will be carried out at 3 months to determine whether the patient is in remission or not.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Management of eosinophilic esophagitis | Other | Other: Digestive endoscopyFollow-up visits are always organized in the same way. A consultation with a gastropediatrician will take place, with assessment of symptoms (PEESS score) and quality of life (PedsQL module for eosinophilic esophagitis and PedsQL 4.0 Generic Core Scales). Then, if treatment needs to be introduced or changed, a digestive endoscopy with biopsies will be carried out at 3 months to determine whether the patient is in remission or not. Depending on the results, the patient may be advised to adapt or maintain the current treatment. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosis of OE according to the diagnostic criteria of the PNDS published in July 2022
- Due to start treatment.
- informed consent from one of the 2 parents or the representative of parental authority.
- Membership of a social security scheme.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Digestive endoscopyDigestive endoscopies are performed in the operative room under general anaesthetic 3 months after the introduction or change of treatment. Biopsies of the upper, middle and lower thirds of the esophagus will be taken and analyzed for pathology. | Other | Management of eosinophilic esophagitis |
Primary outcome
Determine the rate of complete remission
Time frame: at 3 months, 6 months, 12 months, 18 months and 24 months from treatment initiation.
Complete remission will be defined according to the following criteria: 1. Abolition of clinical symptoms as assessed by the Pediatric Eosinophilic Esophagitis Symptom Score 2. Endoscopic score: EoE Endoscopic Reference Score (EREFS) ≤ 2 in the lower, middle and upper thirds of the esophagus. 3. Eosinophilic infiltrate < 5/HPF in standard HES (Haemato-Eosin-Safran) stain on biopsies from lower, middle and upper thirds of esophagus 4. No therapeutic change at follow-up visit to assess remission
2 secondary outcomes
Description at inclusion of a cohort of pediatric patients with OE
Time frame: throught a 24 months follow-up
evolution of quality of life
Time frame: at diagnosis, 3 months, 6 months, 12 months, 18 months and 24 months of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
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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.
Marion Mouchet contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digestive endoscopy in people with Esophagitis, Eosinophilic, run by Fondation Lenval at 1 site in France.
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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 16 Jan 2024. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathilde Butori Pepino, MD (04.92.03.10.12, mathilde.butori@hpu.lenval.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the rate of complete remission (time frame: at 3 months, 6 months, 12 months, 18 months and 24 months from treatment initiation.). 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 16 Jan 2024.