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The Human Microbiome in Immune-Mediated Diseases

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ClinicalTrials.gov Identifier: NCT02394964
Recruitment Status : Active, not recruiting
First Posted : March 20, 2015
Last Update Posted : April 23, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Arthritis Foundation
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date March 16, 2015
First Posted Date March 20, 2015
Last Update Posted Date April 23, 2021
Study Start Date November 2014
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 16, 2015)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 16, 2015)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Human Microbiome in Immune-Mediated Diseases
Official Title The Human Microbiome in Immune-Mediated Diseases
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
whole blood, oral swab, skin swab, stool
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
Condition Autoimmune
Intervention Other: Sample Collection
Sample collection of blood, stool, and buccal and skin swab samples will be collected at baseline, week 4, and week 8
Study Groups/Cohorts
  • Systemic Lupus Erythematosus
    Blood, stool, and swab samples will be collected at baseline, week 4, and week 8 and compared with control samples
    Intervention: 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
    Intervention: Other: Sample Collection
  • Control
    Blood, stool, and swab samples will be collected for comparison to each disease group
    Intervention: Other: Sample Collection
  • Cutaneous T-Cell Lymphoma
    Blood and swab samples will be collected for comparison to each disease group
    Intervention: Other: Sample Collection
  • Autoimmune Disorders
    Blood, stool, and swab samples will be collected for comparison to each disease group
    Intervention: Other: Sample Collection
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: March 16, 2015)
90
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2023
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02394964
Other Study ID Numbers 1408014402
U01AI101990 ( U.S. NIH Grant/Contract )
R01AI118855-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Yale University
Study Sponsor Yale University
Collaborators
  • National Institutes of Health (NIH)
  • Arthritis Foundation
  • National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Martin Kriegel, MD, PhD Yale University
PRS Account Yale University
Verification Date April 2021