Yale MS Clinic
North Haven, Connecticut, 06473, United States
Location status: Recruiting
Location contact
Cynthia Marques
CONTACT
Dimitri Duvilaire
CONTACT
Erin Longbrake, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06329453
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.
Interested in participating?
Request Info18 year–99 year
All sexes
Observational
North Haven, Connecticut, 06473, United States
Location status: Recruiting
Cynthia Marques
CONTACT
Dimitri Duvilaire
CONTACT
Erin Longbrake, MD
PRINCIPAL_INVESTIGATOR
Immune cells and microbes within the GI tract likely play an important role for neurologic disease pathogenesis, including MS and Parkinson's disease. Nevertheless, these immune cells have never been studied in detail using modern single cell technologies. Moreover, most of the human microbiome work done in this space to date has utilized fecal samples, but different anatomic niches within the gut may have greater importance for disease. This study will provide seminal information about how the relationships between gut immunity and neurologic/autoimmune diseases and may be paradigm shifting in regards to how the pathogenesis of some neurologic diseases is viewed.
This is an observational cohort study. Individuals undergoing colonoscopy (+/- upper endoscopy) as a part of standard of care or who consent to have a colonoscopy (+/- upper endoscopy) will be recruited to provide tissue biopsies obtained from the gastrointestinal mucosa. The rationale for including those who are not yet due to have a screening colonoscopy is that for many neurologic diseases (like MS), the disease onset is in adolescence or early adulthood, and the disease is diagnosed in young adults. These individuals would not yet be due to have screening colonoscopies, and yet changes in immune cells within the intestines may be a critical part of disease pathogenesis. This is what the investigators are exploring with this study.
The investigators will need to recruit age matched healthy controls because many features of the immune system change with age; as people get older, the immune system becomes less inflammatory ("immune senescence") and thus it is essential to have age-matched tissues for comparison.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
ONE of the following:
Exclusion criteria
Colonoscopy and colon tissue biopsy.
Time frame: Through study completion, an average of 5 years
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 years
Spatial transcriptomics will be performed on gut mucosal biopsies
Time frame: Through study completion, an average of 5 years
16S and/or shotgun metagenomic sequencing will be utilized to assess the composition of gut microbiome
Contact information is provided by the study sponsor or research team.
Cynthia Marques
CONTACT
Dimitri Duvilaire
CONTACT
Yale University
Other
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.
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