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Sponsored by: |
National Human Genome Research Institute (NHGRI) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00605878 |
This study will examine how microbes (e.g., bacteria, yeast, viruses) that live on human skin interact with each other and with their human host to contribute to health and disease. It will analyze what substances the human cells and microbes produce, how the microbes contribute to human health, and how the balance of these organisms might change in patients with atopic dermatitis, a skin condition also known as eczema.
Healthy volunteers and people with eczema between 3 and 40 years of age may be eligible for this study.
Participants undergo the following tests and procedures:
Participants may be contacted periodically for follow-up studies. Patients with atopic dermatitis may have additional skin samples collected to examine changes in the skin bacteria over time and in all of the stages of eczema. In addition, patients who have a flare of their eczema are asked to undergo a skin sample collection as soon as possible.
Condition |
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Atopic Dermatitis Eczema Ichthyosis Vulgaris |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Studies of Skin Microflora in Healthy Individuals and Atopic Dermatitis Patients |
Estimated Enrollment: | 280 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
We hypothesize that skin microflora (bacteria, fungi, viruses, phage, archae) plays a significant role in common dermatological conditions, such as atopic dermatitis (a common form of eczema). There are two classical explanations for the role microbes play in skin disease: (1) a specific microbe colonizes the skin to disrupt the balance of commensal microflora, or (2) microbes release toxic substances or invade cells to induce an inflammatory response directly. Since culture-dependent skin sampling methods are incomplete and often biased assessments of microbial diversity, we propose to use genomic methods to sample skin microflora and shed light on the above conjectures. A cultivation-independent genomic approach directly sequences the microbial DNA, enabling us to imply microbial community membership, structure and diversity. Our initial study of skin bacteria will analyze the bacterial 16s rRNA gene, which contains highly conserved regions, allowing for amplification with specific primers, that flank highly variable regions. These sequences suggest the identity of the species being sampled and enable us to infer phylogenetic relationships.
Atopic dermatitis (AD, eczema ) is a prevalent chronic disorder that affects ~15% of the population with an age of onset in the first year of life. AD is characterized by barrier-impaired, dry, itchy skin with immune cell infiltration. $1 billion is spent annually in the USA on treatment and associated costs of AD (Bickers, AAD 2006). A recent study has identified the first human genetic alteration that is strongly associated with AD as null mutations in the filaggrin (FLG) gene, which encodes an epidermal structural protein (Sandilands, Nat Gen 2006). These FLG mutations are associated with AD in a semi-dominant fashion and are present in ~47% of European Caucasians with AD. We have recently developed a filaggrin-deficient animal model that shows a selective shift in the microbial community structure, integrating the gene-environment interaction of the host and the microflora.
Chronic eczema is also typical of two rare primary immunodeficiencies: Wiskott Aldrich syndrome (WAS), which is also characterized by impaired cellular and humoral immunity, thrombocytopenia, and increased frequency of infections, and Hyper-IgE syndrome (HIES) which is also characterized, recurrent infections, and increased serum IgE. WAS and HIES are caused by mutations in the WASp and STAT3 genes, respectively.
These studies will investigate changes in microbial diversity associated with AD, WAS, and HIES in pediatric and adult populations to structure future experiments on how to medically manage AD. We will also explore if the progression of eczema is correlated with a selective shift in the skin microbiome specific to the underlying genetic etiology.
Ages Eligible for Study: | 3 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
INCLUSION CRITERIA FOR AD/HIES/WAS PATIENTS (unless specified otherwise):
EXCLUSION CRITERIA FOR AD/HIES/WAS PATIENTS:
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:
EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS AND AGE MATCHED CONTROLS:
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 080059, 08-HG-0059 |
Study First Received: | January 23, 2008 |
Last Updated: | August 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00605878 History of Changes |
Health Authority: | United States: Federal Government |
Atopic Dermatitis (Eczema) Bacteria Filaggrin Skin Microbiome |
Atopic Dermatitis Eczema Health Volunteer HG |
Dominant Ichthyosis Vulgaris Keratosis Dermatitis, Atopic Skin Diseases Skin Abnormalities Healthy Ichthyosis Vulgaris Eczema Lamellar Ichthyosis Ichthyosis |
Hypersensitivity Genetic Diseases, Inborn Hypersensitivity, Immediate Infant, Newborn, Diseases Skin Diseases, Eczematous Congenital Abnormalities Skin Diseases, Genetic Tylosis Dermatitis |
Keratosis Dermatitis, Atopic Skin Diseases Immune System Diseases Skin Abnormalities Eczema Ichthyosis Vulgaris Ichthyosis |
Hypersensitivity Genetic Diseases, Inborn Hypersensitivity, Immediate Infant, Newborn, Diseases Skin Diseases, Eczematous Congenital Abnormalities Skin Diseases, Genetic Dermatitis |