Multiple SclerosisNCT06329453
Intestinal Immunity in Neurologic Disease
An observational study of Multiple Sclerosis and Parkinson Disease, run by Yale University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Parkinson Disease, REM Sleep Behavior Disorder
- What is being tested?
- Colon Tissue Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2022to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale MS Clinic
North Haven, Connecticut, 06473
Cynthia Marques, 2032876100, cynthia.marques@yale.edu
Dimitri Duvilaire, 2032876100, dimitri.duvilaire@yale.edu
About this study
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.
Read the detailed description
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.
- Being tested
- Colon Tissue Biopsy
- Medical subject headings
- Multiple Sclerosis, Parkinson Disease, REM Sleep Behavior Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colon Tissue BiopsyProcedure or surgery
Colonoscopy and colon tissue biopsy.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Individuals | Not described Receives: Procedure: Colon Tissue Biopsy | |
| Individuals with neurologic diseases | Not described Receives: Procedure: Colon Tissue Biopsy | |
| Individuals with known or suspected autoimmune diseases | Not described Receives: Procedure: Colon Tissue Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 5 years
Secondary outcomes (2)
Evaluate spatial transcriptomics of intestinal tissue
Spatial transcriptomics will be performed on gut mucosal biopsies
Measured: Through study completion, an average of 5 years
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
Measured: Through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start2 Aug 2022
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Chan Zuckerberg Biohub, The Brain Research Foundation
- Responsible party
- Principal investigator, Erin E Longbrake, Yale University
- Investigators
- Erin Longbrake, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329453
- Sponsor's protocol ID
- 2000033081
- Status last verified
- May 2026
- First submitted
- 29 Jan 2024
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Immunity in Neurologic Disease
- ClinicalTrials.gov ID
- NCT06329453
- Acronym / sponsor ID
- 2000033081
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Chan Zuckerberg Biohub, The Brain Research Foundation
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 26 Mar 2024 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Individuals | – | Procedure: Colon Tissue Biopsy |
| Individuals with neurologic diseases | – | Procedure: Colon Tissue Biopsy |
| Individuals with known or suspected autoimmune diseases | – | Procedure: Colon Tissue Biopsy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Colon Tissue BiopsyColonoscopy and colon tissue biopsy. | Procedure or surgery | Healthy Individuals, Individuals with known or suspected autoimmune diseases, Individuals with neurologic diseases |
Primary outcome
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.
2 secondary outcomes
Evaluate spatial transcriptomics of intestinal tissue
Time frame: Through study completion, an average of 5 years
Characterize the microbiome at different anatomic sites within the gastrointestinal tract
Time frame: Through study completion, an average of 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No
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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.
Erin Longbrake principal investigator
Yale University
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 Multiple Sclerosis and Parkinson Disease, run by Yale University 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 11 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: looking for participants now, as of the sponsor's last update on 27 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cynthia Marques (2032876100, cynthia.marques@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of immune cells from the gastrointestinal mucosa (time frame: Through study completion, an average of 5 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 27 May 2026.