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OpenTrials
Completed

NCT Number: NCT04704752

Swallowing Characteristics of Pediatric Patients With Eosinophilic Esophagitis

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.

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Key information

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Ankara, 06500, Turkey (Türkiye)

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Swallowing Evaluation

Diagnostic Test

Study Evaluation includes basic test batteries. These are observational.

Primary outcomes

  1. Mastication and Observation Evaluation

    Time frame: 15 minutes

    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.

Secondary outcomes

  1. Pediatric version of the Eating Assessment Tool-10

    Time frame: 10 minutes

    The PEDI-EAT-10 is a parent report outcome instrument to determine penetration and aspiration risk in children.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

Clinical Characteristics of Swallowing in Pediatric Patients With Eosinophilic Esophagitis

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 12, 2021
Registry last updated
Oct 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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