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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06187753
Other study ID # 100714
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 20, 2023
Est. completion date July 20, 2024

Study information

Verified date December 2023
Source Gazi University
Contact Muserrefe Nur Keles, PhD
Phone 5426622464
Email muserrefkeles19@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date July 20, 2024
Est. primary completion date January 20, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 10 Years
Eligibility Inclusion Criteria: - a confirmed diagnosis of EoE - being between 3 and 10 years Exclusion Criteria: - having acute illnesses - having any other chronic diseases

Study Design


Intervention

Diagnostic Test:
Sensory Profile
The Sensory Profile has 125 items that represent 14 functions of sensory processing and allows parents to report on their child's behavior.

Locations

Country Name City State
Turkey Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation Recruiting Ankara, Turkey, 06500 Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline
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