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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04704752
Other study ID # 888819
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 25, 2020
Est. completion date May 20, 2021

Study information

Verified date October 2021
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Eosinophilic Esophagitis (EoE) can affect patients all age group and clinical symptoms of the disease varies depending on the patient's ages. Infants and toddlers with EoE generally have food refusal, vomiting and poor weight gain. Older school-aged children and adolescents may have abdominal and chest pain, difficulty in swallowing (dysphagia) especially in solid foods. In the meantime, many children especially infants and toddlers, are not perceptive of their dysphagia, because they have the ability to compensate. Such as, avoiding certain textures or increases liquid intake in the meal.To date, to our knowledge, there is no study in the literature has investigated complex swallowing behaviour (including all phases), oral-motor evaluation and/or swallowing safety. Thus, the present study purposed to investigate (a) descriptive and clinical swallowing characteristics of children with EoE (b) the relation between disease characteristic and swallowing function.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date May 20, 2021
Est. primary completion date January 25, 2021
Accepts healthy volunteers
Gender All
Age group 2 Years to 17 Years
Eligibility Inclusion Criteria: - Children and adolescents aged 2-17 years with a diagnosis of Eosinophilic Esophagitis Exclusion Criteria: - Do not accommodate the study - Do not want to attempt the study

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Swallowing Evaluation
Study Evaluation includes basic test batteries. These are observational.

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 Mastication and Observation Evaluation Each child was positioned in an upright sitting position in a quiet environment. A standardized biscuit was offered in front of their mouth to bite and chew. Chewing performance of each child was scored according to the T-MOE by observing the child. 15 minutes
Secondary Pediatric version of the Eating Assessment Tool-10 The PEDI-EAT-10 is a parent report outcome instrument to determine penetration and aspiration risk in children. 10 minutes
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