RECRUITING

Intestinal Immunity in Neurologic Disease

Talk to us

Conditions

Multiple SclerosisParkinson DiseaseREM Sleep Behavior Disorder

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Intestinal Immunity in Neurologic Disease

Quick Facts

Study Start:2022-08-02
Study Completion:2027-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06329453

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 and up
  2. * 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
  3. * Willing to undergo research colonoscopy (+/- upper endoscopy) for research
  1. * Currently pregnant. Women of childbearing potential would perform a point of care urine pregnancy test prior to colonoscopy/endoscopy.
  2. * Known or suspected, chronic inflammatory gastrointestinal disease (e.g. inflammatory bowel disease)
  3. * Known, acute or chronic infections
  4. * Systemic antibiotic (PO or IV) use within 3 months of colonoscopy
  5. * Systemic corticosteroid use (equivalent of prednisone 10 mg per day or higher for \>5 days) within 2 weeks of colonoscopy
  6. * Malignancy, diagnosed or treated within the last 5 years
  7. * Probiotic use within 2 weeks of procedure
  8. * History of major GI surgery (e.g. colon resection, gastric bypass)
  9. * Bleeding disorder, or on anticoagulant medication
  10. * Other medical condition that, in the judgement of the investigator, would lead to higher-than-expected risks of biopsy
  11. * Allergy to MAC anesthesia or other drugs used pursuant to standard of care for biospecimen collection

Contacts and Locations

Study Contact

Cynthia Marques
CONTACT
2032876100
cynthia.marques@yale.edu
Dimitri Duvilaire
CONTACT
2032876100
dimitri.duvilaire@yale.edu

Principal Investigator

Erin Longbrake
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

Yale MS Clinic
North Haven, Connecticut, 06473
United States

Collaborators and Investigators

Sponsor: Yale University

  • Erin Longbrake, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-02
Study Completion Date2027-08-31

Study Record Updates

Study Start Date2022-08-02
Study Completion Date2027-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Multiple Sclerosis
  • Parkinson Disease
  • REM Sleep Behavior Disorder