Study Results
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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COMPLETED
10 participants
OBSERVATIONAL
2019-03-14
2022-02-05
Brief Summary
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The investigators are looking for healthy participants 18-25 with no gastrointestinal symptoms to volunteer to have an upper and lower endoscopy and to collect blood and stool samples.
The investigators hope the information gathered in this study will help to better predict and treat these diseases in the future.
Participants who join the study will complete the following activities:
1 hour appointment at Seattle Children's Hospital to determine eligibility Blood Draw Upper and Lower Endoscopy with tissue biopsies Stool Sample collection Participants will get $600 to thank them for their time.
Participants may be eligible for this study if they meet the following requirements:
18 -25 years of age Do not have any abdominal symptoms (vomiting, diarrhea or abdominal pain) Are not on any medications (vitamins and birth control are OK) Have a BMI (body mass index) between 20-25 kg/m\^2 Please note: Interested participants will have a 30 minute phone call with the study team and subsequent 1 hour appointment at Seattle Children's to determine if they meet all of the eligibility criteria.
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Detailed Description
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Research Procedures include:
* Screening questionnaires
* Medical records review
* Height, weight, blood pressure and temperature measurements
* Collection of urine sample for pregnancy test and banking
* Blood sample up to 50ccs(volume based on weight)
* Stool sample
* GI tissue from endoscopy (4-16 biopsies collected from esophagogastroduodenoscopy, 4 -16 biopsies collected from colonoscopy)
Data to be collected:
* Demographics
* Medical history
* Pregnancy test results
* Endoscopy results
* Pathology results
* Clinical data related to endoscopy
* Clinical lab values
Study population:
The study will enroll 10 participants who meet the following criteria:
* Age 18-25
* No signs or symptoms of present illness
* No known history of chronic illness
* Not on any medications other than birth control or vitamin supplementation
* BMI between 10-25 kg/m\^2
* Negative pregnancy test result
Objective/ Purpose:
The samples and information collected from this cohort will be used to understand the mucosal immunity of the gastrointestinal tract in individuals without gastrointestinal problems or history of chronic disease. This information will be used to study the immunology of diseases such as Inflammatory Bowel Disease, Functional Gastrointestinal Disorders and Graft vs. Host Disease.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Esophagogastroduodenoscopy and Colonoscopy with Biopsies
Participants will have an esophagogastroduodenoscopy and colonoscopy with biopsies. Biopsies from esophagogastroduodenoscopy will not exceed 16 pinch biopsies, biopsies from colonoscopy will not exceed 16 pinch biopsies. Participants will have anesthesia for both procedures.
Eligibility Criteria
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Inclusion Criteria
* BMI between 20-25
* Participant as no signs or symptoms of present illness
* Participant has no known chronic illness
Exclusion Criteria
* Pregnancy
18 Years
25 Years
ALL
Yes
Sponsors
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Boston Children's Hospital
OTHER
Seattle Children's Hospital
OTHER
Responsible Party
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Betty Zheng
Principal Investigator
Principal Investigators
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Betty Zheng, MD
Role: PRINCIPAL_INVESTIGATOR
Seattle Children's Hospital
Locations
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Seattle Children's Hospital
Seattle, Washington, United States
Countries
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Other Identifiers
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STUDY00001638
Identifier Type: -
Identifier Source: org_study_id
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