Completed

NCT Number: NCT04369963

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Functional Gastrointestinal Disorders Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

To create a single-cell RNA atlas of healthy gastrointestinal tract from healthy participants

Time frame: 2 years

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.

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Collaborators

Boston Children's Hospital

Registry information

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2022
First posted: Apr 30, 2020
Registry last updated: Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed