Intestinal Immunity in Neurologic Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorYale University
About this trial
The purpose of this study is to ascertain the functional profiles of the immune cells within the gastrointestinal tract and to determine how these cells contribute to autoimmune and neurologic diseases.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18 and up
Recommended to under a screening colonoscopy (+/- upper endoscopy) as part of standard of care. This includes healthy individuals as well as those with neurologic and/or autoimmune diseases. OR
Willing to undergo research colonoscopy (+/- upper endoscopy) for research
Disqualifiers
Currently pregnant. Women of childbearing potential would perform a point of care urine pregnancy test prior to colonoscopy/endoscopy.
Known or suspected, chronic inflammatory gastrointestinal disease (e.g. inflammatory bowel disease)
Known, acute or chronic infections
Systemic antibiotic (PO or IV) use within 3 months of colonoscopy
Trial population
Study participants will be individuals who are having screening colonoscopies (+/- upper endoscopies) and those who are willing to have these procedure/s performed for research, and who are willing to donate tissue for research. Healthy individuals, individuals with neurologic diseases, and individuals with known or suspected autoimmune diseases will all be candidates to participate
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Colon Tissue Biopsy
Procedure/SurgeryColonoscopy and colon tissue biopsy.
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: Healthy Individuals1 intervention
Group B: Individuals with neurologic diseases1 intervention
Group C: Individuals with known or suspected autoimmune diseases1 intervention
Trial outcomes
Primary outcomes
1
Characterization of immune cells from the gastrointestinal mucosa
Gastrointestinal mucosa cells will be characterized using sRNA measured through high-throughput sequencing with quantitative polymerase chain reaction (qPCR) validation.
Time frame
Through study completion, an average of 5 yearsSecondary outcomes
1
Evaluate spatial transcriptomics of intestinal tissue
Spatial transcriptomics will be performed on gut mucosal biopsies
Time frame
Through study completion, an average of 5 years2
Characterize the microbiome at different anatomic sites within the gastrointestinal tract
16S and/or shotgun metagenomic sequencing will be utilized to assess the composition of gut microbiome
Time frame
Through study completion, an average of 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Chan Zuckerberg Biohub
Collaborator
The Brain Research Foundation
Collaborator
Source ClinicalTrials.gov