NCT02394964

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2014

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 20, 2015

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

December 21, 2023

Status Verified

December 1, 2023

Enrollment Period

9.1 years

First QC Date

March 16, 2015

Last Update Submit

December 20, 2023

Conditions

Autoimmune

Outcome Measures

Primary Outcomes (1)

  • Difference in Commensal bacteria

    Difference in disease group vs. control commensal bacteria will be compared by looking at the relative abundances of the microbiota

    8 weeks

Secondary Outcomes (1)

  • Immune Cross-reactivity with commensal bacteria

    8 weeks

Study Arms (5)

Systemic Lupus Erythematosus

Blood, stool, and swab samples will be collected at baseline, week 4, and week 8 and compared with control samples

Other: Sample Collection

Subacute Cutaneous Lupus Erythematosus

Blood, stool, and swab samples will be collected at baseline, week 4, and week 8 and compared with control samples

Other: Sample Collection

Control

Blood, stool, and swab samples will be collected for comparison to each disease group

Other: Sample Collection

Cutaneous T-Cell Lymphoma

Blood and swab samples will be collected for comparison to each disease group

Other: Sample Collection

Autoimmune Disorders

Blood, stool, and swab samples will be collected for comparison to each disease group

Other: Sample Collection

Interventions

Sample CollectionOTHER

Sample collection of blood, stool, and buccal and skin swab samples will be collected at baseline, week 4, and week 8

Autoimmune DisordersControlCutaneous T-Cell LymphomaSubacute Cutaneous Lupus ErythematosusSystemic Lupus Erythematosus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with immune-mediated disorders including but not limited to: systemic lupus, cutaneous lupus, Sjogren's Syndrome, mixed connective tissue disease, dermatomyositis/polymyositis, celiac sprue with or without dermatitis herpetiformis, scleroderma, ANCA-associated vasculitis

You may qualify if:

  • 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

You may not qualify if:

  • Ongoing chronic infection (viral, bacterial or fungal) including known HIV, Hepatitis B/C
  • 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)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yale New Haven Hospital

New Haven, Connecticut, 06519, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (6)

  • 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.

    PMID: 32457482BACKGROUND

  • 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.

    PMID: 30581114RESULT

  • 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.

    PMID: 31227334RESULT

  • 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.

    PMID: 29593104RESULT

  • 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.

    PMID: 29590047RESULT

  • 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.

    PMID: 39874239DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, oral swab, skin swab, stool

MeSH Terms

Interventions

Specimen Handling

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Martin Kriegel, MD, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2015

First Posted

March 20, 2015

Study Start

November 1, 2014

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

December 21, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(2)