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View Clinical Trial (Medical Research Study)
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Studies of Skin Microbes in Healthy People and in People With Skin Conditions - NCT00605878-20892 (Clinical Trial 201237)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy201237.aspx
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| City: |
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Bethesda |
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State:
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MD |
| Zip Code: |
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20892 |
| Conditions: |
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Atopic Dermatitis - Eczema - Ichthyosis Vulgaris |
| Purpose: |
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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:
- Medical history, including medication and family history
- Skin examination
- Blood tests
- Skin samples to analyze microbes. Samples are obtained by the following methods:
swabbing the skin with a cotton swab; scraping the skin gently with a blade to remove
only the most exterior layers of skin; and only in adults, biopsy (surgical removal) of
a small skin sample less than ?-inch (5 mm) in diameter.
- Nose swabs to analyze microbes.
- Patients with eczema may have photographs of their skin taken to help monitor the skin
rashes.
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.
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| Study summary: |
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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. |
| Criteria: |
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- INCLUSION CRITERIA:
Inclusion Criteria for all groups
1. All subjects: Minimum age of 2 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. All subjects: Must have a primary care professional who will continue care/evaluation
in tandem with the protocol to whom information can be communicated.
Inclusion Criteria for Group 1: Healthy Volunteers
1. Adult males or females WITHOUT asthma or allergic rhinitis aged 18-40.
2. Subset of males or females 2 - 40 years of age who MAY have asthma or allergic
rhinitis, from whom MRSA isolates will be obtained.
Inclusion Criteria for Group 3: Age-Matched Controls
1. Males or females 2- 18 years of age.
2. Interval visits and age of controls must match those of enrolled AD patients.
Inclusion Criteria for Groups 2, 4, & 5: AD/HIES/WAS patients (unless specified
otherwise)
1. AD patients: Diagnosis of atopic dermatitis on the basis of the criteria defined by
UK Working Party's Diagnostic Criteria for Atopic Dermatitis.
2. AD patients: SCORAD (SCORing Atopic Dermatitis) score of greater than or equal to 25
indicating AD severity of moderate to severe.
3. AD patients: At least one antecubital (or popliteal) fossae must be affected at the
time of enrollment to serve as a target site.
4. HIES or WAS patients: Must have mutation-proven diagnosis, with or without eczematous
dermatitis.
EXCLUSION CRITERIA:
Exclusion Criteria for all groups:
1. Any 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. Any 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. Any subjects who are currently or have previously received treatment with
chemotherapy or radiation for treatment of malignancies within the previous 6 months.
4. Any subject with a chronic disease requiring treatment; e.g. diabetes, bone marrow
transplant, hepatitis.
Exclusion Criteria specific for groups 2, 4 & 5: AD/HIES/WAS patients (unless specified
otherwise):
1. 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 greater than or equal to 7 days to small areas of skin
intended for sampling. (Topical therapies/emollients for AD may be continued to
non-adjacent, non-target sites.)
2. AD patients: Subjects with underlying immunodeficiency, either as primary disease or
secondary to treatment.
3. WAS/HIES patients: unable to remain off topical steroids and emollients for
preferably 7 days but at least 24 hours prior to skin sampling. HIES/WAS patients
will not be taken off their systemic (oral) antibiotics or systemic (oral) steroids.
If unable to withhold topical therapies/emollients may be continued to non-adjacent,
non-target sites.)
Exclusion Criteria specific for Groups 1 & 3: Healthy Volunteers and Age-Matched
Controls (In addition to the general exclusion criteria listed above for all groups unless
specified otherwise):
1. Subjects with underlying immunodeficiency, either as primary disease or secondary to
treatment.
2. 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.
3. 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.
4. Subjects with asthma or allergic rhinitis, except for the subset of Group 1 healthy
volunteers designated as those undergoing sampling for MRSA isolates.
5. Children with past or ongoing parasitic infection.
Children who immigrated to the U.S. within the last 5 years. |
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| Study is available at: |
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National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, MD 20892
United States
Primary Contact:
Patient Recruitment and Public Liaison Office
Email: prpl@mail.cc.nih.gov
Phone: (800) 411-1222 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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