Clinical Trials

Sensory Processing Issues in Eosinophilic Esophagitis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	3 Years - 10 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- a confirmed diagnosis of EoE.

- being between 3 and 10 years.

Exclusion Criteria:

- having acute illnesses.

- having any other chronic diseases

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06187753
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Gazi University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Muserrefe Nur Keles, PhD
Principal Investigator Affiliation	Gazi University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Turkey
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Eosinophilic Esophagitis, Sensory Disorder

Additional Details

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.

Arms & Interventions

Arms

: 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.

: 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.

Interventions

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.

Contact a Trial Team

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International Sites

Ankara, Turkey

Status

Recruiting

Address

Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation Recruiting Ankara, Turkey, 06500

Ankara, , 06500

Site Contact

Muserref KELES, PhD

[email protected]

5426622464 #+90

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