Autoimmune
Conditions
Brief summary
The immune system is influenced by the commensal microbes that live in the gut and on the skin. This study aims to characterize the microbiota of subjects with autoimmune disease in order to determine whether certain microbial species may cause or worsen immune-mediated diseases
Detailed description
This is a combination of a defined pilot microbiome study as well as exploratory mechanistic research with candidate commensals identified based on known structures accessible in public databases. In the observational prospective two-center study, subjects will be followed for 8 weeks. The study will consist of a total of 3 study visits (0, 4 and 8 weeks). Screening and baseline visits (week 0) will take place at the same time. A study window period of +/- 7 days will be allowed for follow-up study visits. The mechanistic in vitro research with subjects' blood cells and candidate commensals will typically require between 2-4 visits for sampling, but will not be limited by the frequency of visits.
Interventions
OTHERSample Collection
Sample collection of blood, stool, and buccal and skin swab samples will be collected at baseline, week 4, and week 8
Sponsors
National Institutes of Health (NIH)
Arthritis Foundation
National Institute of Allergy and Infectious Diseases (NIAID)
Yale University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years of age and older * Diagnosis of an immune-mediated disease by a healthcare provider, including but not limited to: systemic lupus erythematosus, subacute cutaneous lupus erythematosus
Exclusion criteria
for pilot study (subjects enrolled in the exploratory mechanistic study arm will not be required to meet
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Commensal bacteria | 8 weeks | Difference in disease group vs. control commensal bacteria will be compared by looking at the relative abundances of the microbiota |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immune Cross-reactivity with commensal bacteria | 8 weeks | T and B cells in patients with immune-mediated diseases will cross react with specific microbial antigens |
Countries
United States
Outcome results
None listed