- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06187753
Sensory Processing Issues in Eosinophilic Esophagitis
Sensory Processing Issues in Children With Eosinophilic Esophagitis
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Muserrefe Nur Keles, PhD
- Phone Number: +90 5426622464
- Email: muserrefkeles19@gmail.com
Study Locations
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Ankara, Turkey, 06500
- Recruiting
- Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation Recruiting Ankara, Turkey, 06500
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Contact:
- Muserref KELES, PhD
- Phone Number: +90 5426622464
- Email: muserref-1@hotmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- a confirmed diagnosis of EoE
- being between 3 and 10 years
Exclusion Criteria:
- having acute illnesses
- having any other chronic diseases
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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The Sensory Profile has 125 items that represent 14 functions of sensory processing and allows parents to report on their child's behavior.
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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.
|
The Sensory Profile has 125 items that represent 14 functions of sensory processing and allows parents to report on their child's behavior.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensory Profile
Time Frame: Baseline
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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.
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Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Muserrefe Nur Keles, PhD, Gazi University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Nervous System Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Neurologic Manifestations
- Hematologic Diseases
- Gastrointestinal Diseases
- Gastroenteritis
- Hypersensitivity
- Esophageal Diseases
- Leukocyte Disorders
- Eosinophilia
- Eosinophilic Esophagitis
- Esophagitis
- Sensation Disorders
Other Study ID Numbers
- 100714
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Eosinophilic Esophagitis
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Children's Hospital Medical Center, CincinnatiNational Institute of Allergy and Infectious Diseases (NIAID); National Institute... and other collaboratorsCompletedEosinophilic Esophagitis (EoE) | Eosinophilic Gastrointestinal Disorders (EGIDs)United States
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AQILION ABCompletedEosinophilic Esophagitis (EoE)United Kingdom
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ShireCompletedEosinophilic Esophagitis (EoE)United States
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Christopher BarwaczCompletedEsthetics, Dental | Dental Implant, Single-ToothUnited States
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Lena BornhoftRegion Västra Götaland, Sweden; Region Värmland, SwedenCompletedLifestyle Risk ReductionSweden
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