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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 |
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, or eczema) is a prevalent chronic disorder that affects approximately 15 percent 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. One billion dollars are spent annually in the USA on treatment and associated costs of AD. 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. These FLG mutations are associated with AD in a semi-dominant fashion and are present in approximately 47 percent 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.
These studies will investigate changes in microbial diversity associated with AD in pediatric and adult populations to structure future experiments on how to medically manage AD.
Ages Eligible for Study: | 3 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
INCLUSION CRITERIA FOR AD PATIENTS:
EXCLUSION CRITERIA FOR AD PATIENTS:
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: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00605878 |
Health Authority: | United States: Federal Government |
Atopic Dermatitis (Eczema) Bacteria Filaggrin Skin Microbiome |
Atopic Dermatitis Eczema Health Volunteer HG |
Keratosis Dermatitis, Atopic Skin Diseases Keratosis follicularis spinulosa decalvans Skin Abnormalities Healthy Ichthyosis Vulgaris Eczema Lamellar ichthyosis Ichthyosis Hypersensitivity |
Genetic Diseases, Inborn Hypersensitivity, Immediate Infant, Newborn, Diseases Skin Diseases, Eczematous Ichthyosis vulgaris Congenital Abnormalities Dominant ichthyosis vulgaris Skin Diseases, Genetic Tylosis Dermatitis |
Immune System Diseases |