Eosinophilic Esophagitis Clinical Trial
Official title:
Clinical Characteristics of Swallowing in Pediatric Patients With Eosinophilic Esophagitis
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 |
Verified date | October 2021 |
Source | Gazi University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation Recruiting Ankara, Turkey, 06500 | Ankara |
Lead Sponsor | Collaborator |
---|---|
Gazi University |
Turkey,
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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