- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04704752
Swallowing Characteristics of Pediatric Patients With Eosinophilic Esophagitis
October 14, 2021 updated by: Muserrefe Nur Keles, Gazi University
Clinical Characteristics of Swallowing in 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
52
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey, 06500
- Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation Recruiting Ankara, Turkey, 06500
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 17 years (Child)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children and adolescents aged 2-17 years with a diagnosis of Eosinophilic Esophagitis
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 25, 2020
Primary Completion (Actual)
January 25, 2021
Study Completion (Actual)
May 20, 2021
Study Registration Dates
First Submitted
January 8, 2021
First Submitted That Met QC Criteria
January 8, 2021
First Posted (Actual)
January 12, 2021
Study Record Updates
Last Update Posted (Actual)
October 15, 2021
Last Update Submitted That Met QC Criteria
October 14, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 888819
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
We have not decided yet.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Eosinophilic Esophagitis
-
Children's Hospital Medical Center, CincinnatiNational Institute of Allergy and Infectious Diseases (NIAID); National Institute... and other collaboratorsCompletedEosinophilic Esophagitis (EoE) | Eosinophilic Gastrointestinal Disorders (EGIDs)United States
-
Federico II UniversityRecruitingEsophagitis, EosinophilicItaly
-
Ann & Robert H Lurie Children's Hospital of ChicagoRecruitingEosinophilic Gastroenteritis | Eosinophilic Esophagitis | Eosinophilic Colitis | Eosinophilic Gastrointestinal DiseaseUnited States
-
Medical University of GrazRecruiting
-
AQILION ABCompletedEosinophilic Esophagitis (EoE)United Kingdom
-
Regeneron PharmaceuticalsSanofiActive, not recruitingEosinophilic Esophagitis (EoE)United States, Canada
-
ShireTakeda Development Center Americas, Inc.TerminatedEosinophilic Esophagitis (EoE)United States
-
ShireCompletedEosinophilic Esophagitis (EoE)United States
-
ShireCompleted
-
ShireCompletedEosinophilic Esophagitis (EoE)United States
Clinical Trials on Swallowing Evaluation
-
University Hospital, ToulouseNational Research Agency, France; Laboratoire parole et langage; Swallis Medical and other collaboratorsRecruiting
-
University Hospital, ToursCompletedPeripheral Facial ParalysisFrance
-
University of Wisconsin, MadisonCompleted
-
Fondazione Policlinico Universitario Agostino Gemelli...Recruiting
-
University of GiessenRecruitingSpinal Muscular AtrophyGermany
-
Saint-Joseph UniversityUnknownDysphagia Following Cerebral Infarction
-
University Hospital MuensterCompletedNeurogenic Dysphagia | Flexible Endoscopic Evaluation of SwallowingGermany
-
University of FloridaCompleted
-
University of FloridaCompleted
-
University of FloridaCompleted