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Title: Skin Microbiome in Disease States: Atopic Dermatitis and Immunodeficiency      
Identifier:
phs000266.v2.p1
description:
The NIH Intramural Skin Microbiome Consortium (NISMC) is a collaboration of investigators with primary expertise in genomics, bioinformatics, large-scale DNA sequencing, dermatology, immunology, allergy, infectious disease, and clinical microbiology. Atopic dermatitis (AD, "eczema") is a chronic relapsing skin disorder that affects ~15% of U.S. children and is associated with $1 billion of medical costs annually. AD is characterized by dry, itchy skin, infiltrated with immune cells. Colonization by Staphylococcus aureus (S. aureus) is ten-fold more common in AD patients and is associated with disease flares. We hypothesize that, in addition to S. aureus, AD may also be associated with additional novel microbes and/or selective shifts of commensal microbes that are relevant to disease progression. The NISMC seeks to define the microbiota that resides in and on the skin and nares of three patient groups, all of whom have eczematous lesions and are currently seen at the NIH Clinical Center: (1) AD patients; (2) Wiskott-Aldrich syndrome (WAS) patients; and (3) Hyper IgE syndrome (HIES) patients. Examination of the microbiome of patients with WAS or HIES syndromes, both rare immunodeficiencies, will advance our understanding of how an individual's immune system shapes their cutaneous microbial community. We are performing a prospective longitudinal study that follows these groups of patient thorough the cycles of eczema flares, ascertaining clinical data and samples at each stage.
accesstypes:
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landingpage: http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000266.v2.p1
authentication: simpleLogin
none
authorization:
none
duaIndividual
name:
Dermatitis, Atopic
Jobs Syndrome
Wiskott-Aldrich Syndrome
affiliations:
National Human Genome Research Institute, National Institutes of Health, Bethesda, MD, USA
name:
Julia Segre, PhD
roles:
Principal Investigator
affiliations:
National Cancer Institute, Center for Cancer Research, National Institutes of Health, Bethesda, MD, USA
name:
Heidi Kong, MD
roles:
Medical Advisor
affiliations:
National Institutes of Health, Bethesda, MD, USA
name:
NIH Common Fund: Human Microbiome Project
roles:
Funding Source
performedBy:
TitleNameInstitute Principal InvestigatorJulia Segre, PhDNational Human Genome Research Institute, National Institutes of Health, Bethesda, MD, USA Medical AdvisorHeidi Kong, MDNational Cancer Institute, Center for Cancer Research, National Institutes of Health, Bethesda, MD, USA Funding SourceNIH Common Fund: Human Microbiome ProjectNational Institutes of Health, Bethesda, MD, USA
downloadURL: https://dbgap.ncbi.nlm.nih.gov/aa/wga.cgi?page=DUC&view_pdf&stacc=phs000266.v2.p1
Identifier:
phs000266.v2.p1_policy
name:
Data Use Certificate
Identifier:
1
name:
Human Microbiome Research
schedulesActivity:
Hyper-IgE patients are medically managed and diagnosed at the NIH Clinical Center under NIAID's protocol: NCT00006150 Wiskott Aldrich patients are medically managed and diagnosed at the NIH Clinical Center under NHGRI's protocol: NCT00006319
alternateIdentifiers:
yes
selectionCriteria:

Inclusion Criteria for AD/HIES/WAS patients (unless specified otherwise):

  1. Males or females 3 - 40 years of age. Minimum age of 3 enriches for patients that have active AD and are statistically less likely to resolve during this longitudinal study. Maximum age of 40 is to reduce chance of recruiting patients with age-related changes in skin.
  2. AD patients: Diagnosis of atopic dermatitis on the basis of the criteria defined by UK Working Party's Diagnostic Criteria for Atopic Dermatitis. (Reference: Williams HC, Burney PG, Pembroke AC, et al: The U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis. III. Independent hospital validation. Br J Dermatol 131:406-16, 1994, PMID: 7918015).
  3. HIES or WAS patients: Must have mutation-proven diagnosis, with or without eczematous dermatitis.
  4. AD patients: SCORAD (SCORing Atopic Dermatitis) score of ≥ 25 indicating AD severity of moderate to severe. Included in appendix. (Reference: Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology. 1993;186(1):23-31, PMID: 2078538).
  5. AD patients: At least one antecubital (or popliteal) fossae must be affected at the time of enrollment to serve as a target site.
  6. Must have a primary care professional who will continue care/evaluation in tandem with the protocol to whom information can be communicated.

Exclusion Criteria for AD/HIES/WAS patients:

  1. Subjects with unstable or uncontrolled medical conditions that could require hospitalization during the course of the study or who have been hospitalized in the last month.
  2. Subjects receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants < 7 days or 5 half-lives (whichever is the longer time period) of initiating this protocol.
  3. AD patients: Subjects who are unable to remain off systemic (oral) antibiotics or systemic (oral) steroids for at least 7 days prior to skin sample collection. Subjects who are unable to temporarily discontinue use of topical steroids or calcineurin inhibitors for ≥ 7 days to small areas of skin intended for sampling. (Topical therapies for AD may be continued to non-adjacent, non-target sites.)
  4. AD patients: Subjects with underlying immunodeficiency, either as primary disease or secondary to treatment.
  5. WAS/HIES patients: unable to remain off topical steroids and emollients (skin sampling sites only) for at least 24 hours prior to skin sampling. HIES/WAS patients will not be taken off their systemic (oral) antibiotics or systemic (oral) steroids. (Topical therapies may be continued to non-adjacent, non-target sites.)
  6. Subjects who are currently or have previously received treatment with chemotherapy or radiation for treatment of malignancies.
  7. Subject with a chronic disease requiring treatment; e.g. diabetes, bone marrow transplant, hepatitis.

Inclusion Criteria for Healthy Volunteers and Age Matched Controls:

  1. Males or females 3 - 40 years of age.
  2. Interval visits and age of controls must match enrolled AD patients

Exclusion Criteria for Healthy Volunteers and Age Matched Controls:

  1. Subjects with unstable or uncontrolled medical conditions that could require hospitalization during the course of the study or who have been hospitalized in the last month.
  2. Subjects receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants < 7 days or 5 half-lives (whichever is the longer time period) of initiating this protocol.
  3. Subjects who are unable to remain off systemic (oral) antibiotics or systemic (oral) steroids for at least 7 days.
  4. Subjects with underlying immunodeficiency, either as primary disease or secondary to treatment.
  5. Subjects who are currently or have previously received treatment with chemotherapy or radiation.
  6. Subject with a chronic disease requiring treatment; e.g. diabetes, bone marrow transplant, hepatitis.
  7. Subject with other documented chronic dermatologic disease, such as AD or psoriasis that may interfere with evaluation of cutaneous microbiome. Common transient conditions, such as acne, are permissible.
  8. Subjects who work or reside in healthcare facilities or in non-hospital settings that provide healthcare such as assisted living facilities, homeless shelters, jails and prisons as well as subjects with frequent exposure to laboratory animals, in order to minimize potential ascertainment bias. Certain pathogens such as Staphylococcus aureus and multi-drug resistant organisms are disproportionately associated with delivery of healthcare.

dateReleased:
09-02-2011
version:
phs000266.v2.p1
dateModified:
09-02-2011
abbreviation:
JARDE
name:
Joint NIAMS-NIDCR Data Access Committee
ID:
0
name:
dbGaP

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