Inflammatory Bowel DiseasesNCT04369963
The Healthy Endoscopy Study
An observational study of Inflammatory Bowel Diseases and Functional Gastrointestinal Disorders, run by Seattle Children's Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases, Functional Gastrointestinal Disorders
- What is being tested?
- Esophagogastroduodenoscopy and Colonoscopy with Biopsies
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2019to 5 Feb 2022
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Age 18 -25
- BMI between 20-25
- Participant as no signs or symptoms of present illness
- Participant has no known chronic illness
Who cannot join
- On medications other than birth control or vitamins
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Hospital
Seattle, Washington, 98105
About this 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.
Read more
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.
Read the 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.
- Being tested
- Esophagogastroduodenoscopy and Colonoscopy with Biopsies
- Medical subject headings
- Inflammatory Bowel Diseases, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophagogastroduodenoscopy and Colonoscopy with BiopsiesProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start14 Mar 2019
- Primary completion1 Jul 2021
- Study completion5 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital
- Responsible party
- Principal investigator, Betty Zheng, Seattle Children's Hospital
- Investigators
- Betty Zheng, MD, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369963
- Sponsor's protocol ID
- STUDY00001638
- Status last verified
- Apr 2024
- First submitted
- 28 Apr 2020
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Healthy Endoscopy Study
- ClinicalTrials.gov ID
- NCT04369963
- Acronym / sponsor ID
- STUDY00001638
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Boston Children's Hospital
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 5 Feb 2022 (actual)
- First posted
- 30 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- Age 18 -25
- BMI between 20-25
- Participant as no signs or symptoms of present illness
- Participant has no known chronic illness
Key exclusion criteria (2 listed)
- On medications other than birth control or vitamins
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esophagogastroduodenoscopy and Colonoscopy with BiopsiesParticipants 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. | Procedure or surgery | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Inflammatory Bowel Diseases
RecruitingPhase 2
A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis
Ulcerative Colitis, Inflammatory Bowel Diseases
Active, not recruiting
Virtual Incision Robotically Assisted Surgical Device Use in Minimally Invasive Colectomy
Colon Cancer, Colon Polyp
Not yet recruiting
Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
Anal Fistula, Rectal Fistula
Enrolling by invitationPhase 2
Long-term Safety and Efficacy of Multiple Long-acting Antibodies Alone and in Combinations for IBD
Ulcerative Colitis, Inflammatory Bowel Diseases
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
Ulcerative Colitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Betty Zheng, MD principal investigator
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Functional Gastrointestinal Disorders, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To create a single-cell RNA atlas of healthy gastrointestinal tract from healthy participants (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.