Recruiting

Observational Study

Sponsor:

Yale University

Code:

NCT06329453

Conditions

Multiple Sclerosis

Parkinson Disease

REM Sleep Behavior Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Colon Tissue Biopsy

Study Details

Brief 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.

Conditions

Multiple Sclerosis

Parkinson Disease

REM Sleep Behavior Disorder

Study ID

NCT06329453

Start date

Aug 2, 2022

Status verified date

May, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy Individuals

Individuals with neurologic diseases

Individuals with known or suspected autoimmune diseases

Interventions

Colon Tissue Biopsy

Colonoscopy and colon tissue biopsy.

Primary outcome measure

  • Characterization of immune cells from the gastrointestinal mucosa [ Time Frame: Through study completion, an average of 5 years ]

Central Contacts and Locations

Central contacts

Cynthia Marques

2032876100cynthia.marques@yale.edu

Dimitri Duvilaire

2032876100dimitri.duvilaire@yale.edu

Locations

Yale MS Clinic

Recruiting

North Haven, Connecticut, United States, 06473

Contacts

Cynthia Marques

2032876100cynthia.marques@yale.edu

Dimitri Duvilaire

2032876100dimitri.duvilaire@yale.edu

Principal Investigator:

Erin Longbrake, MD

More Information

Sponsor

Yale University

Last update posted

May 27, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-05-27.