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Somatization, Anxiety, and Disordered Sleep in Pediatric Eosinophilic Esophagitis

Study Purpose

Eosinophilic esophagitis

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 8 Years - 18 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04309786
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of California, San Diego
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Esophagitis
Additional Details

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).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Rady Children's Hospital San Diego, San Diego, California

Status

Recruiting

Address

Rady Children's Hospital San Diego

San Diego, California, 92123

Site Contact

Kira Chaiboonma, BS

kchaiboonma@health.ucsd.edu

858-966-1700 #226884

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