Actively Recruiting
Effects of Treatments on the Microbiome in Healthy Volunteers and Patients With Atopic Dermatitis
Led by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Updated on 2026-06-01
130
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how treatments for atopic dermatitis, a chronic skin condition often accompanied by bacterial infections, affect the types and amounts of bacteria on the skin. This research focuses on both patients with moderate to severe eczema aged 2 to 50 years and healthy volunteers aged 18 to 50 years without eczema. The study aims to better understand how antimicrobial treatments impact the skin microbiome over time. Participants are randomly assigned to different treatment groups that include various antibiotic regimens such as cephalexin, doxycycline at different doses, and trimethoprim/sulfamethoxazole, as well as placebo capsules and dilute bleach baths. Treatments are given orally or as topical baths over periods ranging from 14 to 56 days. Some participants may receive combined treatments of antibiotics and bleach baths, and others may receive placebo treatments. The study involves a longitudinal design with repeated sampling and follow-up visits. During the one-year participation, all volunteers and patients undergo regular visits for physical exams, medical history reviews, and collection of skin and microbiome samples, including possible skin biopsies. The research team monitors changes in the skin bacteria and evaluates treatment effects using clinical assessments like the SCORAD score. Safety and treatment responses are tracked, and healthy volunteers might have an additional follow-up visit after one year. The primary outcome is to characterize changes in the skin microbiome within two weeks of treatment.
CONDITIONS
Brief Title
Effects of Treatments on Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy volunteers aged 18 to 50 years at time of initial protocol sampling
- Willingness to comply fully with study procedures
- Co-enrollment in NIH protocol 08-HG-0059
- Ability to understand and provide written informed consent
- Access to bathing facilities (for some cohorts)
- Ability to swallow capsules or tablets
- Patients aged 2 to 50 years with a diagnosis of atopic dermatitis
- Moderate to severe atopic dermatitis indicated by SCORAD score ≥ 15
- Signs of bacterial skin infection before treatment
- Having a primary care provider
- Pediatric patients included with age-appropriate assent and consent
- Previous cohort participants who completed antibiotic regimen and consent to participate
You will not qualify if you...
- Not meeting inclusion criteria
- Females with symptoms or hormone levels indicating perimenopause or menopause
- Use of systemic antibiotics within 12 months before baseline (healthy volunteers) or within 8 weeks before baseline (patients)
- Use of swimming pools, hot tubs, or whirlpools in 7 days before baseline
- Use of topical or oral complementary/alternative medicine within 4 weeks before treatment
- Known allergies to sulfa, beta-lactam, tetracycline drugs, lidocaine, epinephrine, or sodium hypochlorite
- Family history of toxic epidermal necrolysis
- History of atopic dermatitis or asthma (healthy volunteers)
- Inability to comply with protocol
- Pregnant or lactating females
- Immunodeficiency including HIV positivity
- Chronic skin diseases like psoriasis or other chronic illnesses
- Receiving or planning to receive investigational drugs, ultraviolet therapy, monoclonal antibodies, or systemic immunosuppressants
- Current or recent chemotherapy or radiation therapy
- Residing or working in healthcare or similar facilities with frequent exposure to lab animals
- Smokers and users of smokeless tobacco products due to unknown effects on microbiome
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 14 to 56 days depending on assigned treatment
Participants receive randomized antimicrobial treatments including oral antibiotics and/or dilute bleach baths to study their effects on the microbiome and atopic dermatitis.
Multiple visits during treatment period depending on treatment regimen
Duration - Up to 1 year or more after treatment
Participants undergo longitudinal microbiome sampling and optional follow-up visits to evaluate persistent microbiome changes after treatment completion.
Optional single visit more than 1 year after treatment for some participants
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
H
Heidi H Kong, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
10
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