The Healthy Endoscopy Study

NCT04369963 | Completed

• 1 other identifier: STUDY00001638
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammatory Bowel Diseases; Functional Gastrointestinal Disorders

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Esophagogastroduodenoscopy and Colonoscopy with Biopsies PROCEDURE

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

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• On medications other than birth control or vitamins
• Pregnancy

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• Boston Children's Hospital: collaborator

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

GI tissue biopsies, stool, blood

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Gastrointestinal Diseases

Interventions

Endoscopy, Digestive System; Colonoscopy; Biopsy

Condition Hierarchy (Ancestors)

Gastroenteritis; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Endoscopy, Gastrointestinal; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Specimen Handling; Investigative Techniques

Study Officials

• Betty Zheng, MD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: April 30, 2020
• Study Start: March 14, 2019
• Primary Completion: July 1, 2021
• Study Completion: February 5, 2022
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data and specimens will be stored indefinitely and may be shared at any point in the study's duration
• 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

Locations

US (1)