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NCT Number: NCT06329453

Intestinal Immunity in Neurologic Disease

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 18 and up

ONE of the following:

  • 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

Exclusion criteria

  • 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
  • Systemic corticosteroid use (equivalent of prednisone 10 mg per day or higher for >5 days) within 2 weeks of colonoscopy
  • Malignancy, diagnosed or treated within the last 5 years
  • Probiotic use within 2 weeks of procedure
  • History of major GI surgery (e.g. colon resection, gastric bypass)
  • Bleeding disorder, or on anticoagulant medication
  • Other medical condition that, in the judgement of the investigator, would lead to higher-than-expected risks of biopsy
  • Allergy to MAC anesthesia or other drugs used pursuant to standard of care for biospecimen collection

Treatment and study plan

Colon Tissue Biopsy

Procedure

Colonoscopy and colon tissue biopsy.

Primary outcomes

  1. Characterization of immune cells from the gastrointestinal mucosa

    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.

Secondary outcomes

  1. Evaluate spatial transcriptomics of intestinal tissue

    Time frame: Through study completion, an average of 5 years

    Spatial transcriptomics will be performed on gut mucosal biopsies

  2. Characterize the microbiome at different anatomic sites within the gastrointestinal tract

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Cynthia Marques

CONTACT

[email protected]

2032876100

Dimitri Duvilaire

CONTACT

[email protected]

2032876100

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Chan Zuckerberg Biohub
  • National Institutes of Health (NIH)
  • The Brain Research Foundation

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 26, 2024
Registry last updated
May 27, 2026

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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