The Human Microbiome in Immune-Mediated Diseases

Description

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

Study Start Date

November 2014

Estimated Completion Date

November 2016

Interventions

  • Other: Sample Collection

Specialties

  • Internal Medicine: Allergy/Immunology
  • Allergy/Immunology: Rheumatic/Autoimmune

MeSH Terms

  • Autoimmune

Study ID

Yale University -- 1408014402

Status

Unknown

Trial ID

NCT02394964

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

90

Sponsor

Yale University

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

  • 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)
  • Diabetes Mellitus, poorly controlled (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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (2)

Study Location Distance Name Phone Email
Yale New Haven Hospital - New Haven, Connecticut 17.3 miles Martin Kriegel MD PhD 203-737-8326 martin.kriegel@yale.edu
Hospital for Special Surgery - New York, New York 48.5 miles None None None

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