Metabolic Profiling of Immune Responses in Immune-mediated Diseases

Recruiting

• Conditions: Atopic Dermatitis; Immune-mediated Diseases; Primary Immunodeficiency; Psoriasis

• Registration Number: NCT04864886
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

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.

Detailed Description

Study Description:

This is an exploratory sample collection study enrolling adult healthy volunteers and patients with immune-mediated diseases to elucidate the metabolic signatures associated with immune-mediated diseases. We hypothesize that activation of, and responses to, specific immune pathways will require metabolic changes within cells, serum, and skin.

Following screening and baseline procedures, including blood draw, participants will undergo skin biopsies. The skin biopsies will involve up to 4 biopsies: 2 initial punch biopsies 2 mm in diameter, optionally followed by 1 or 2 punch biopsies 3 (+/-1) days later using a 3-mm punch to encompass the initial biopsy site(s), capturing the tissue at 3 days of healing. There will be an option for blister induction to maximize keratinocyte collection. Blister induction involves creating 8 blisters on the forearm and removing the tops of the blisters for primary cell culture derivation. In addition, skin swabs and tape strips may be collected to assess for microbial or host markers of epithelial repair. Peripheral blood will be collected with the initial biopsies to compare metabolic signatures in peripheral blood cells and serum with those in the skin. After day 0 (or 3, if the participant has that optional visit), participation in the study will be complete.

Objectives:

Primary Objectives:

1. Evaluate metabolic profiles in immune activation associated with known or suspected immune-mediated disorders.

2. Determine whether there are abnormalities in specific tissue repair pathways, such as epithelial to mesenchymal transition (EMT), that are associated with immune-mediated disorders.

Secondary Objectives:

Not applicable.

Endpoints:

Primary Endpoints:

1. Fold differences in metabolic pathways associated with immune pathways.

2. Fold differences in metabolic pathways related to wound healing.

3. Change in relative abundance of microbial skin taxa and/or skin metabolites associated with wound healing or immune-mediated disorders.

Secondary Endpoints:

Not applicable.

Study Timeline

• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-04-28
• Study First Posted: 2021-04-29
• Study Start: 2021-08-10
• Status Verified: 2024-11-06
• Last Update Submitted: 2024-11-09
• Last Update Posted: 2024-11-12
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in relative abundance of microbial skin taxa and/or skin metabolites associated with wound healing or immune mediated disorders.	Throughout study	Determine whether there are abnormalities in specific tissue repair pathways, such as epithelial to mesenchymal transition (EMT) are associated with immune-mediated disorders.
Fold difference in metabolic pathways associated with immune pathways.	Throughout study	Evaluate metabolic profiles in immune activation associated with known or suspected immune-mediated disorders.
Fold differences in metabolic pathways related to wound healing.	Throughout study	Determine whether there are abnormalities in specific tissue repair pathways, such as epithelial to mesenchymal transition (EMT) are associated with immune-mediated disorders.

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States