The Healthy Endoscopy Study

Researchers at Seattle Children's Research Institute want to find ways to understand gastrointestinal disease such as Inflammatory Bowel Disease (IBD), Irritable Bowel Syndrome (IBS) and Graft-Versus-Host-Disease (GVHD). We want to compare healthy cells from the gastrointestinal tract to cells from people with gastrointestinal diseases.

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Functional Gastrointestinal Disorders
• Intervention / Treatment: Procedure: Esophagogastroduodenoscopy and Colonoscopy with Biopsies

Detailed Description

This study will enroll a cohort of healthy individuals age 18-25 to volunteer for an esophagogastroduodenoscopy and colonoscopy and will collect of gastrointestinal tissue biopsy samples, blood and stool samples.

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.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

You may be eligible for this study if you are:

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 mas index) between 20-25 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 you meet all of the eligibility criteria.

Description

Inclusion Criteria:

• Age 18 -25
• BMI between 20-25
• Participant as no signs or symptoms of present illness
• Participant has no known chronic illness

Exclusion Criteria:

• On medications other than birth control or vitamins
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To create a single-cell RNA atlas of healthy gastrointestinal tract from healthy participants	A single-cell RNA atlas of the healthy gastrointestinal tract will be created through flow cytometry, T Cell receptor deep sequencing, single cell transcriptome analysis and whole transcriptome analysis on immune cells purified from GI tissue samples and peripheral blood.	2 years

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Collaborators: Boston Children's Hospital
• Investigators: Principal Investigator: Betty Zheng, MD, Seattle Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2019
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): February 5, 2022

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: April 28, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: STUDY00001638

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Collaborators in Leslie Kean's lab at Boston Children's Hospital will have access to coded data and specimens. Data and specimens that may be shared include: GI tissue samples, whole blood, urine, stool, cDNA, and clinical data without identifying information.
• IPD Sharing Time Frame: Data and specimens will be stored indefinitely and may be shared at any point in the study's duration
• IPD Sharing Access Criteria: Study team members at Seattle Children's will have access to patient records and specimens with identification. Collaborator's at Boston Children's will have access to coded specimens and data at request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No