Somatization, Anxiety, and Disordered Sleep in Pediatric Eosinophilic Esophagitis

NCT ID: NCT04309786

Last Updated: 2022-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

98 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-11

Study Completion Date

2021-04-26

Brief Summary

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Eosinophilic esophagitis

Detailed Description

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In order to decrease disease burden and the perception of disease burden, investigators need to understand the symptoms and severity of anxiety, disordered sleep, and somatization and how these parameters align with symptoms and quality of life in pediatric EoE. To assess the burden of these parameters in children with EoE, investigators will conduct a single center pilot study of 60 children with EoE using validated indexes for anxiety (state trait anxiety inventory for children), somatization (children's somatization inventory), sleep (pediatric sleep questionnaire), coping (Connor-Davidson Resilience Score) symptoms (PEESSv2.0), and quality of life (PedsQL-EoE).

Conditions

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Eosinophilic Esophagitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age 8-18 years old
* Ability to understand and complete the surveys and complete them in English
* Known diagnosis of EoE defined as \> 15 eosinophils per high power field. Patient can have active or inactive disease at the time of entry

Exclusion Criteria

* \<8 or \> 18 years old
* Inability to read the surveys in English
* Concurrent gastrointestinal diseases such as inflammatory bowel disease or Celiac disease.
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University

OTHER

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Seema Aceves

Professor, Pediatrics and Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rady Children's Hospital San Diego

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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190374

Identifier Type: -

Identifier Source: org_study_id

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