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The Healthy Endoscopy Study

The Healthy Endoscopy Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04369963
Enrollment
10
Registered
2020-04-30
Start date
2019-03-14
Completion date
2022-02-05
Last updated
2024-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Gastrointestinal Disorders, Inflammatory Bowel Diseases

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.

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.

Interventions

PROCEDUREEsophagogastroduodenoscopy 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.

Sponsors

Boston Children's Hospital
CollaboratorOTHER
Seattle Children's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
To create a single-cell RNA atlas of healthy gastrointestinal tract from healthy participants2 yearsA 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026