Metabolic Profiling of Immune Responses in Immune-mediated Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
About this trial
Background:
The immune system is the part of the body that fights infection. Some people have immune deficiencies that cause skin rashes, make them get sick often with infections, or make it difficult for their skin to heal. Researchers want to learn more to better treat conditions that affect immune response.
Objective:
To learn about how the immune system and skin healing are related to each other.
Eligibility:
People ages 18-75 with primary immune deficiency, eczema, or psoriasis. Healthy volunteers are also needed.
Design:
Participants will be screened with a medical and medicine history and a physical exam. They may take a pregnancy test.
Participants will discuss the medicines or supplements they take as well as skin products they use, such as soaps and lotions.
Participants will have up to 4 skin biopsies taken from the forearm. A needle will inject an anesthetic into the skin where the biopsy will be done. A sharp tool that looks like a tiny cookie cutter will be used to remove a round plug of skin a bit smaller than the tip of a pencil.
Participants will give at least 1 blood sample.
Participants may have optional skin swab collection. A cotton swab will be used to swab the skin on the arm.
Participants may have optional skin tape collection. A sticky strip of tape will be placed on the arm and then removed.
Participants may give leftover samples taken as part of their regular medical care.
Participation will last for about 4 days. Participants will have 2 visits that each last about 1 hour. They may be asked to repeat the study in the future.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Has documentation of PID confirmed by genetic evaluation demonstrating a deleterious variant in the gene (or genes) known to be associated with immune deficiency (confirmed PID); or
Has documented variant of undetermined significance in a gene (or genes) that is predicted to be deleterious in immune function by the investigators OR a clinical history of infections which are more frequent, more chronic, or more severe than normal (suspected PID); or
Has physician-diagnosed psoriasis; or
Has physician-diagnosed AD; or
Disqualifiers
Current or prior (within 3 months) anticoagulant or anti-platelet therapy (other than aspirin or non-steroidal anti-inflammatory drugs).
Current or prior (within 3 months) use of immunomodulatory drugs (eg, chemotherapy, steroids), except if approved by the principal investigator.
History of keloid formation.
Pregnancy, lactating, or breastfeeding.
Trial population
Healthy volunteers will be recruited through the Clinical Research Volunteer Program. We anticipate that most patient participants will be existing CC participants referred from ongoing NIH protocols;they may also be self-referred through their own initiative or referred by outside physicians.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 4 trial groupsGroup A: Healthy volunteers
Group B: Patients with atopic dermatitis
Group C: Patients with primary immunodeficiency
Group D: Patients with psoriasis
Trial outcomes
Primary outcomes
1
Change in relative abundance of microbial skin taxa and/or skin metabolites associated with wound healing or immune mediated disorders.
Determine whether there are abnormalities in specific tissue repair pathways, such as epithelial to mesenchymal transition (EMT) are associated with immune-mediated disorders.
Time frame
Throughout study2
Fold difference in metabolic pathways associated with immune pathways.
Evaluate metabolic profiles in immune activation associated with known or suspected immune-mediated disorders.
Time frame
Throughout study3
Fold differences in metabolic pathways related to wound healing.
Determine whether there are abnormalities in specific tissue repair pathways, such as epithelial to mesenchymal transition (EMT) are associated with immune-mediated disorders.
Time frame
Throughout studySponsors and contacts
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Source ClinicalTrials.gov