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The Human Microbiome in Immune-Mediated Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02394964
Recruitment Status : Active, not recruiting
First Posted : March 20, 2015
Last Update Posted : January 4, 2022
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Arthritis Foundation
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Yale University

Study Description
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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

Condition or disease Intervention/treatment
Autoimmune Other: Sample Collection

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Human Microbiome in Immune-Mediated Diseases
Study Start Date : November 2014
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : December 2023
Groups and Cohorts
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Group/Cohort Intervention/treatment
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
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
 Other: 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
 Other: 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
 Other: 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
 Other: Sample Collection
Sample collection of blood, stool, and buccal and skin swab samples will be collected at baseline, week 4, and week 8


Outcome Measures
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Primary Outcome Measures :
  1. Difference in Commensal bacteria [ Time Frame: 8 weeks ]
    Difference in disease group vs. control commensal bacteria will be compared by looking at the relative abundances of the microbiota


Secondary Outcome Measures :
  1. Immune Cross-reactivity with commensal bacteria [ Time Frame: 8 weeks ]
    T and B cells in patients with immune-mediated diseases will cross react with specific microbial antigens


Biospecimen Retention:   Samples With DNA
whole blood, oral swab, skin swab, stool

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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
Criteria

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 exclusion criteria and may be enrolled if the investigators believe that the subject can help address the scientific aim)..

Exclusion Criteria:

  • 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)
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02394964


Locations
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United States, Connecticut
Yale New Haven Hospital
New Haven, Connecticut, United States, 06519
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Yale University
National Institutes of Health (NIH)
Arthritis Foundation
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Martin Kriegel, MD, PhD Yale University
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02394964    
Other Study ID Numbers: 1408014402
U01AI101990 ( U.S. NIH Grant/Contract )
R01AI118855-01 ( U.S. NIH Grant/Contract )
First Posted: March 20, 2015    Key Record Dates
Last Update Posted: January 4, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No