Eosinophilic EsophagitisNCT04704752
Swallowing Characteristics of Pediatric Patients With Eosinophilic Esophagitis
An observational study of Eosinophilic Esophagitis, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Eosinophilic Esophagitis (EoE) can affect patients all age group and clinical symptoms of the disease varies depending on the patient's ages. Infants and toddlers with EoE generally have food refusal, vomiting and poor weight gain. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Swallowing Evaluation
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 May 2020to 20 May 2021
- How long will I take part?
- 1 Day
- 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 2 to 17 years
- All sexes
- Child
Study population: Children and adolescents aged 2-17 years with a diagnosis of Eosinophilic Esophagitis
Who may be able to join
- Children and adolescents aged 2-17 years with a diagnosis of Eosinophilic Esophagitis
Who cannot join
- Do not accommodate the study
- Do not want to attempt the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation Recruiting Ankara, Turkey, 06500
Ankara, 06500
About this study
Official title: Clinical Characteristics of Swallowing in Pediatric Patients With Eosinophilic Esophagitis
Eosinophilic Esophagitis (EoE) can affect patients all age group and clinical symptoms of the disease varies depending on the patient's ages. Infants and toddlers with EoE generally have food refusal, vomiting and poor weight gain. Older school-aged children and adolescents may have abdominal and chest pain, difficulty in swallowing (dysphagia) especially in solid foods. In the meantime, many children especially infants and toddlers, are not perceptive of their dysphagia, because they have the ability to compensate. Such as, avoiding certain textures or increases liquid intake in the meal.To date, to our knowledge, there is no study in the literature has investigated complex swallowing behaviour (including all phases), oral-motor evaluation and/or swallowing safety. Thus, the present study purposed to investigate (a) descriptive and clinical swallowing characteristics of children with EoE (b) the relation between disease characteristic and swallowing function.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Swallowing Evaluation
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swallowing EvaluationDiagnostic test
Study Evaluation includes basic test batteries. These are observational.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mastication and Observation Evaluation
Each child was positioned in an upright sitting position in a quiet environment. A standardized biscuit was offered in front of their mouth to bite and chew. Chewing performance of each child was scored according to the T-MOE by observing the child.
Measured: 15 minutes
Secondary outcomes (1)
Pediatric version of the Eating Assessment Tool-10
The PEDI-EAT-10 is a parent report outcome instrument to determine penetration and aspiration risk in children.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start25 May 2020
- Primary completion25 Jan 2021
- Study completion20 May 2021
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.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muserrefe Nur Keles, Gazi University
- Investigators
- Bulent Elbasan, PhD, Study chair, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704752
- Sponsor's protocol ID
- 888819
- Status last verified
- Oct 2021
- First submitted
- 8 Jan 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We have not decided yet.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics of Swallowing in Pediatric Patients With Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT04704752
- Acronym / sponsor ID
- 888819
- Conditions
- Eosinophilic Esophagitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 25 May 2020 (actual)
- Primary completion
- 25 Jan 2021 (actual)
- Study completion
- 20 May 2021 (actual)
- First posted
- 12 Jan 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.
Eosinophilic Esophagitis (EoE) can affect patients all age group and clinical symptoms of the disease varies depending on the patient's ages. Infants and toddlers with EoE generally have food refusal, vomiting and poor weight gain. Older school-aged children and adolescents may have abdominal and chest pain, difficulty in swallowing (dysphagia) especially in solid foods. In the meantime, many children especially infants and toddlers, are not perceptive of their dysphagia, because they have the ability to compensate. Such as, avoiding certain textures or increases liquid intake in the meal.To date, to our knowledge, there is no study in the literature has investigated complex swallowing behaviour (including all phases), oral-motor evaluation and/or swallowing safety. Thus, the present study purposed to investigate (a) descriptive and clinical swallowing characteristics of children with EoE (b) the relation between disease characteristic and swallowing function.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- Children and adolescents aged 2-17 years with a diagnosis of Eosinophilic Esophagitis
Key inclusion criteria (1 listed)
- Children and adolescents aged 2-17 years with a diagnosis of Eosinophilic Esophagitis
Key exclusion criteria (2 listed)
- Do not accommodate the study
- Do not want to attempt the study
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 |
|---|---|---|
| Swallowing EvaluationStudy Evaluation includes basic test batteries. These are observational. | Diagnostic test | – |
Primary outcome
Mastication and Observation Evaluation
Time frame: 15 minutes
Each child was positioned in an upright sitting position in a quiet environment. A standardized biscuit was offered in front of their mouth to bite and chew. Chewing performance of each child was scored according to the T-MOE by observing the child.
1 secondary outcome
Pediatric version of the Eating Assessment Tool-10
Time frame: 10 minutes
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 15 Oct 2021.
- Individual participant dataSharing planned: Undecided. We have not decided yet.
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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.
Bulent Elbasan, PhD study chair
Gazi 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 Gazi University at 1 site in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 15 Oct 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 Turkey (Türkiye). 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?
Mastication and Observation Evaluation (time frame: 15 minutes). 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 15 Oct 2021.