Eosinophilic EsophagitisNCT06187753
Sensory Processing Issues in Eosinophilic Esophagitis
An observational study of Eosinophilic Esophagitis and Sensory Disorder, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Feeding dysfunction and/or dysphagia are the main symptoms of eosinophilic esophagitis (EoE). Also, these symptoms may be a part of sensory processing disorders. Therefore, the present study compared sensory processing abilities between children with EoE and typically developing (TD) controls. Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Eosinophilic Esophagitis, Sensory Disorder
- What is being tested?
- Sensory Profile
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Aug 2023to 20 Jul 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 3 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with eosinophilic esophagitis and age-matched typically developing peers
Who may be able to join
- a confirmed diagnosis of EoE
- being between 3 and 10 years
Who cannot join
- having acute illnesses
- having any other chronic diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation Recruiting Ankara, Turkey, 06500
Ankara, 06500
Muserref KELES, PhD, 5426622464 ext. +90, muserref-1@hotmail.com
About this study
Official title: Sensory Processing Issues in Children With Eosinophilic Esophagitis
Feeding dysfunction and/or dysphagia are the main symptoms of eosinophilic esophagitis (EoE). Also, these symptoms may be a part of sensory processing disorders. Therefore, the present study compared sensory processing abilities between children with EoE and typically developing (TD) controls.
Read the detailed description
Eosinophilic Esophagitis (EoE) is a chronic allergic/immune condition of the esophagus that affects all ages, from infancy through adulthood. The chronic inflammation can lead to symptoms that vary with age. It is critically important to know symptoms in the infancy/toddler period because in this period, they can't express symptoms directly. The frequent symptoms seen in this period are; vomiting, refusing sucking and eating, failure to thrive, and abdominal pain. School-aged children with EoE have decreased appetite, recurrent abdominal pain, vomiting, food impaction, and dysphagia. Feeding dysfunction (feeding refusal, slowly eating, picky eater, etc..) is one of the trouble issues in this period. Children who can't experience different texture (especially solid) and tastes of foods keep on eating with their same safe feeding habits. Whereas experiences gained in early childhood period form the basis of sensory and motor development. As currently known, humans have eight senses (visual, auditory, gustatory, olfactory, tactile, proprioception, vestibular, and interoception). Each sense is unique, a form of information and nourishment for the nervous system. In the meantime, it is crucial to receive, interpret, and integrate all this information from all these senses at a time. Sensory integration (SI) is the term used for the brain processing information that comes through the senses. The SI begins in the womb as the fetal brain senses the movements. Childhood activities and play lead to a lot of sensory integration as the child organizes the sensations of his body and gravity, along with sight and sound. If there is a problem in any sense, such as receiving or interpreting, the SI process can be interrupted, and this may result in sensory processing disorder (SPD). It is crucial to notice SPD in childhood because SPD can affect a child's development and education (learning, reading, math, visual and auditory perception, and skilled motor tasks).
Food intake is one of the most multi-sensory daily experiences (sight, smell, taste, sounds, texture of food) for both children and adults. In children with EoE, feeding dysfunction (vomiting, food impaction, regurgitation..) can affect the oral sensory system. Even considering that all the senses work in interaction, more senses can be affected.
To date, there is no study that has investigated sensory processing issues in children with EoE. Therefore, the present study aimed to compare sensory processing between children with EoE and healthy controls and also examine the correlations between sensory processing and disease characteristics among children with EoE.
- Conditions
- Eosinophilic Esophagitis, Sensory Disorder
- Being tested
- Sensory Profile
- Medical subject headings
- Eosinophilic Esophagitis, Sensation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory ProfileDiagnostic test
The Sensory Profile has 125 items that represent 14 functions of sensory processing and allows parents to report on their child's behavior.
| Study group | Role | What they receive |
|---|---|---|
| Children with Eosinophilic Esophagitis | Children with Eosinophilic Esophagitis The first group will consist 30 children with definite EoE diagnoses who were between ages 3 and 10 years. The Sensory Profile will used to evaluate sensory processing. This questionnaire will be completed by parents who record a child's responses to sensory events in daily life. Receives: Diagnostic Test: Sensory Profile | |
| Children with Typically Developing | Typically Developing Children The second group will consist of 30 children with typically developing who were between ages 3 and 10 years. The Sensory Profile will used to evaluate sensory processing. This questionnaire will be completed by parents who record a child's responses to sensory events in daily life. Receives: Diagnostic Test: Sensory Profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory Profile
The questionnaire has 125 items that represent 14 functions of sensory processing and allows parents to report on their child's behavior. The questionnaire uses a five-point rating scale, with a score of '1' indicating always or 100%, '2' indicating frequently or at least 75%, '3' indicating occasionally or 50%, '4' indicating seldom or 25%, and '5' indicating never or 0%. Six categories defined by the Sensory Profile are related to sensory processing areas, while five categories relate to sensory modulation, and the last three categories reflect social-emotional responses related to sensory processing. The test also provides nine sensory profile factor scores that reflect sensory processing styles.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start20 Aug 2023
- Primary completion20 Jan 2024 (estimated)
- Study completion20 Jul 2024 (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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muserrefe Nur Keles, Gazi University
- Investigators
- Muserrefe Nur Keles, PhD, Study chair, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187753
- Sponsor's protocol ID
- 100714
- Status last verified
- Dec 2023
- First submitted
- 17 Dec 2023
- Last updated
- 3 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 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Processing Issues in Children With Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT06187753
- Acronym / sponsor ID
- 100714
- Conditions
- Eosinophilic Esophagitis, Sensory Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 20 Aug 2023 (actual)
- Primary completion
- 20 Jan 2024 (estimated)
- Study completion
- 20 Jul 2024 (estimated)
- First posted
- 3 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.
Feeding dysfunction and/or dysphagia are the main symptoms of eosinophilic esophagitis (EoE). Also, these symptoms may be a part of sensory processing disorders. Therefore, the present study compared sensory processing abilities between children with EoE and typically developing (TD) controls.
Detailed description
Eosinophilic Esophagitis (EoE) is a chronic allergic/immune condition of the esophagus that affects all ages, from infancy through adulthood. The chronic inflammation can lead to symptoms that vary with age. It is critically important to know symptoms in the infancy/toddler period because in this period, they can't express symptoms directly. The frequent symptoms seen in this period are; vomiting, refusing sucking and eating, failure to thrive, and abdominal pain. School-aged children with EoE have decreased appetite, recurrent abdominal pain, vomiting, food impaction, and dysphagia. Feeding dysfunction (feeding refusal, slowly eating, picky eater, etc..) is one of the trouble issues in this period. Children who can't experience different texture (especially solid) and tastes of foods keep on eating with their same safe feeding habits. Whereas experiences gained in early childhood period form the basis of sensory and motor development. As currently known, humans have eight senses (visual, auditory, gustatory, olfactory, tactile, proprioception, vestibular, and interoception). Each sense is unique, a form of information and nourishment for the nervous system. In the meantime, it is crucial to receive, interpret, and integrate all this information from all these senses at a time. Sensory integration (SI) is the term used for the brain processing information that comes through the senses. The SI begins in the womb as the fetal brain senses the movements. Childhood activities and play lead to a lot of sensory integration as the child organizes the sensations of his body and gravity, along with sight and sound. If there is a problem in any sense, such as receiving or interpreting, the SI process can be interrupted, and this may result in sensory processing disorder (SPD). It is crucial to notice SPD in childhood because SPD can affect a child's development and education (learning, reading, math, visual and auditory perception, and skilled motor tasks).
Food intake is one of the most multi-sensory daily experiences (sight, smell, taste, sounds, texture of food) for both children and adults. In children with EoE, feeding dysfunction (vomiting, food impaction, regurgitation..) can affect the oral sensory system. Even considering that all the senses work in interaction, more senses can be affected.
To date, there is no study that has investigated sensory processing issues in children with EoE. Therefore, the present study aimed to compare sensory processing between children with EoE and healthy controls and also examine the correlations between sensory processing and disease characteristics among children with EoE.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with Eosinophilic Esophagitis | – | Diagnostic Test: Sensory ProfileChildren with Eosinophilic Esophagitis The first group will consist 30 children with definite EoE diagnoses who were between ages 3 and 10 years. The Sensory Profile will used to evaluate sensory processing. This questionnaire will be completed by parents who record a child's responses to sensory events in daily life. |
| Children with Typically Developing | – | Diagnostic Test: Sensory ProfileTypically Developing Children The second group will consist of 30 children with typically developing who were between ages 3 and 10 years. The Sensory Profile will used to evaluate sensory processing. This questionnaire will be completed by parents who record a child's responses to sensory events in daily life. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with eosinophilic esophagitis and age-matched typically developing peers
Key inclusion criteria (2 listed)
- a confirmed diagnosis of EoE
- being between 3 and 10 years
Key exclusion criteria (2 listed)
- having acute illnesses
- having any other chronic diseases
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 |
|---|---|---|
| Sensory ProfileThe Sensory Profile has 125 items that represent 14 functions of sensory processing and allows parents to report on their child's behavior. | Diagnostic test | Children with Eosinophilic Esophagitis, Children with Typically Developing |
Primary outcome
Sensory Profile
Time frame: Baseline
The questionnaire has 125 items that represent 14 functions of sensory processing and allows parents to report on their child's behavior. The questionnaire uses a five-point rating scale, with a score of '1' indicating always or 100%, '2' indicating frequently or at least 75%, '3' indicating occasionally or 50%, '4' indicating seldom or 25%, and '5' indicating never or 0%. Six categories defined by the Sensory Profile are related to sensory processing areas, while five categories relate to sensory modulation, and the last three categories reflect social-emotional responses related to sensory processing. The test also provides nine sensory profile factor scores that reflect sensory processing styles.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 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. This study is not recruiting at the moment.
Muserrefe Nur Keles, 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 and Sensory Disorder, 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 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 3 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muserrefe Nur Keles, PhD (5426622464 ext. +90, muserrefkeles19@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory Profile (time frame: Baseline). 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 3 Jan 2024.