NCT06187753

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 3, 2024

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2024

Completed
Last Updated

January 3, 2024

Status Verified

December 1, 2023

Enrollment Period

5 months

First QC Date

December 17, 2023

Last Update Submit

December 17, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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.

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.

Diagnostic Test: Sensory Profile

Interventions

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.

Children with Eosinophilic EsophagitisChildren with Typically Developing

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children with eosinophilic esophagitis and age-matched typically developing peers

You may qualify if:

  • a confirmed diagnosis of EoE
  • being between 3 and 10 years

You may not qualify if:

  • having acute illnesses
  • having any other chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ankara, 06500, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Eosinophilic EsophagitisSensation Disorders

Condition Hierarchy (Ancestors)

EsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Muserrefe Nur Keles, PhD

    Gazi University

    STUDY CHAIR

Central Study Contacts

Muserrefe Nur Keles, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 17, 2023

First Posted

January 3, 2024

Study Start

August 20, 2023

Primary Completion

January 20, 2024

Study Completion

July 20, 2024

Last Updated

January 3, 2024

Record last verified: 2023-12

Locations