Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
75 participants
OBSERVATIONAL
2014-11-30
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Systemic Lupus Erythematosus
Blood, stool, and swab samples will be collected at baseline, week 4, and week 8 and compared with control samples
Sample Collection
Sample collection of blood, stool, and buccal and skin swab samples will be collected at baseline, week 4, and week 8
Subacute Cutaneous Lupus Erythematosus
Blood, stool, and swab samples will be collected at baseline, week 4, and week 8 and compared with control samples
Sample Collection
Sample collection of blood, stool, and buccal and skin swab samples will be collected at baseline, week 4, and week 8
Control
Blood, stool, and swab samples will be collected for comparison to each disease group
Sample Collection
Sample collection of blood, stool, and buccal and skin swab samples will be collected at baseline, week 4, and week 8
Cutaneous T-Cell Lymphoma
Blood and swab samples will be collected for comparison to each disease group
Sample Collection
Sample collection of blood, stool, and buccal and skin swab samples will be collected at baseline, week 4, and week 8
Autoimmune Disorders
Blood, stool, and swab samples will be collected for comparison to each disease group
Sample Collection
Sample collection of blood, stool, and buccal and skin swab samples will be collected at baseline, week 4, and week 8
Interventions
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Sample Collection
Sample collection of blood, stool, and buccal and skin swab samples will be collected at baseline, week 4, and week 8
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of an immune-mediated disease by a healthcare provider, including but not limited to: systemic lupus erythematosus, subacute cutaneous lupus erythematosus
Exclusion Criteria
* Acute infection receiving any antibiotics or any use of antibiotics within 90 days prior to screening
* For skin swab collection (see also appendix D):
* No use of topical antibiotics within 7-days prior to collection of swab, other than use in normal hand washing.
* No use of topical antimicrobial products (as outlined in appendix F) within 48 hours prior to collection of swab
* Subject must not have bathed within 8-hours of swab collection.
* For oral swab collection (see also appendix D):
* No use of antiseptic mouth washes (as outlined in appendix F) within 48 hours of swab collection
* Subjects must not have brushed teeth or flossed within 8-hours of swab collection
* Major gastrointestinal surgery less than 5 years prior to enrollment (with the exception of appendectomy)
* Any Gastrointestinal bleeding history
* Inflammatory Bowel Disease diagnosed by biopsy
* Bulimia or anorexia nervosa
* Probiotics (greater than estimated 109 cfu or organisms per day) within 90 days prior to enrollment (with the exception of fermented beverages, milks or yogurts).
* Morbid obesity (BMI ≥ 40)
* Type I Diabetes Mellitus
* Diabetes Mellitus type 2, poorly controlled defined as Hgb A1c greater than 8% on medical therapy
* Malignancy within one year prior to screening (with the exception of non-metastatic squamous or basal cell skin carcinomas and cervical carcinoma if received curative surgical treatment)
* Known illicit drug or alcohol abuse
18 Years
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
Arthritis Foundation
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Martin Kriegel, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale New Haven Hospital
New Haven, Connecticut, United States
Hospital for Special Surgery
New York, New York, United States
Countries
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References
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Ruff WE, Greiling TM, Kriegel MA. Host-microbiota interactions in immune-mediated diseases. Nat Rev Microbiol. 2020 Sep;18(9):521-538. doi: 10.1038/s41579-020-0367-2. Epub 2020 May 26.
Zegarra-Ruiz DF, El Beidaq A, Iniguez AJ, Lubrano Di Ricco M, Manfredo Vieira S, Ruff WE, Mubiru D, Fine RL, Sterpka J, Greiling TM, Dehner C, Kriegel MA. A Diet-Sensitive Commensal Lactobacillus Strain Mediates TLR7-Dependent Systemic Autoimmunity. Cell Host Microbe. 2019 Jan 9;25(1):113-127.e6. doi: 10.1016/j.chom.2018.11.009. Epub 2018 Dec 20.
Ruff WE, Dehner C, Kim WJ, Pagovich O, Aguiar CL, Yu AT, Roth AS, Vieira SM, Kriegel C, Adeniyi O, Mulla MJ, Abrahams VM, Kwok WW, Nussinov R, Erkan D, Goodman AL, Kriegel MA. Pathogenic Autoreactive T and B Cells Cross-React with Mimotopes Expressed by a Common Human Gut Commensal to Trigger Autoimmunity. Cell Host Microbe. 2019 Jul 10;26(1):100-113.e8. doi: 10.1016/j.chom.2019.05.003. Epub 2019 Jun 18.
Greiling TM, Dehner C, Chen X, Hughes K, Iniguez AJ, Boccitto M, Ruiz DZ, Renfroe SC, Vieira SM, Ruff WE, Sim S, Kriegel C, Glanternik J, Chen X, Girardi M, Degnan P, Costenbader KH, Goodman AL, Wolin SL, Kriegel MA. Commensal orthologs of the human autoantigen Ro60 as triggers of autoimmunity in lupus. Sci Transl Med. 2018 Mar 28;10(434):eaan2306. doi: 10.1126/scitranslmed.aan2306.
Manfredo Vieira S, Hiltensperger M, Kumar V, Zegarra-Ruiz D, Dehner C, Khan N, Costa FRC, Tiniakou E, Greiling T, Ruff W, Barbieri A, Kriegel C, Mehta SS, Knight JR, Jain D, Goodman AL, Kriegel MA. Translocation of a gut pathobiont drives autoimmunity in mice and humans. Science. 2018 Mar 9;359(6380):1156-1161. doi: 10.1126/science.aar7201.
Zhou H, Balint D, Shi Q, Vartanian T, Kriegel MA, Brito I. Lupus and inflammatory bowel disease share a common set of microbiome features distinct from other autoimmune disorders. Ann Rheum Dis. 2025 Jan;84(1):93-105. doi: 10.1136/ard-2024-225829. Epub 2025 Jan 2.
Other Identifiers
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