Swallowing Characteristics of Pediatric Patients With Eosinophilic Esophagitis
Clinical Characteristics of Swallowing in Pediatric Patients With Eosinophilic Esophagitis
1 other identifier
observational
52
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2020
Shorter than P25 for all trials
1 active site
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
May 25, 2020
CompletedFirst Submitted
Initial submission to the registry
January 8, 2021
CompletedFirst Posted
Study publicly available on registry
January 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2021
CompletedOctober 15, 2021
October 1, 2021
8 months
January 8, 2021
October 14, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Pediatric version of the Eating Assessment Tool-10
10 minutes
Interventions
Study Evaluation includes basic test batteries. These are observational.
Eligibility Criteria
Children and adolescents aged 2-17 years with a diagnosis of Eosinophilic Esophagitis
You may qualify if:
- Children and adolescents aged 2-17 years with a diagnosis of Eosinophilic Esophagitis
You may not qualify if:
- Do not accommodate the study
- Do not want to attempt the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gazi Universitylead
Study Sites (1)
Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation Recruiting Ankara, Turkey, 06500
Ankara, 06500, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Bulent Elbasan, PhD
Gazi University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
January 8, 2021
First Posted
January 12, 2021
Study Start
May 25, 2020
Primary Completion
January 25, 2021
Study Completion
May 20, 2021
Last Updated
October 15, 2021
Record last verified: 2021-10