NCT04704752

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

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2021

Completed
Last Updated

October 15, 2021

Status Verified

October 1, 2021

Enrollment Period

8 months

First QC Date

January 8, 2021

Last Update Submit

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

Swallowing EvaluationDIAGNOSTIC_TEST

Study Evaluation includes basic test batteries. These are observational.

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (1)

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

Ankara, 06500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

EsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Bulent Elbasan, PhD

    Gazi University

    STUDY CHAIR

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

Locations