Probiotic Supplementation for Prevention of Atopic Dermatitis in Infants and Children: A Systematic Review and Meta-analysis.
Lin Li, Zhen Han, Xiaoping Niu...
https://pubmed.ncbi.nlm.nih.gov/30465329Actively Recruiting
Phase 2
Age: 2Years - 100Years
All Genders
ID06096857
A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Trial of Cardamom and Topical Roseomonas in Atopic Dermatitis
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-06-08
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a topical treatment containing Roseomonas mucosa bacteria combined with ground cardamom seeds for people aged 2 years and older who have atopic dermatitis (AD), a chronic skin condition that causes dryness, itching, and can lead to other health problems like asthma and allergies. This phase 2b, double-blind, randomized clinical trial aims to see if this treatment improves AD symptoms compared to a placebo. The study also looks at how the treatment affects skin bacteria and quality of life over time. Participants will receive a freeze-dried study product by mail, which they will mix with water and apply as a spray to their skin two to three times weekly for 14 weeks. Half of the participants will get the active treatment containing the bacteria and cardamom, while the other half will get a placebo that looks the same but does not contain the bacteria. After 14 weeks of treatment, all applications stop, and participants are followed for another 14 weeks to observe lasting effects. Skin swabs will be collected remotely during three study visits, and participants may choose to send photos of their skin. During the approximately 7-month study, participants will complete five remote visits and fill out four online questionnaires about their symptoms and quality of life. Researchers will monitor eczema severity, itch levels, use of topical steroids, and changes in the skin’s microbiome. Safety and ease of using the product will also be evaluated. The main goal is to assess improvement in AD symptoms 14 weeks after stopping treatment.
CONDITIONS
Brief Title
Cardamom and Topical Roseomonas in Atopic Dermatitis
Who Can Participate
Age: 2Years - 100Years
All Genders
Eligibility Criteria
You may qualify if you...
- Aged 2 years or older
- Have a documented primary care provider near residence
- Fluent in English (participant or caregiver)
- Clinical diagnosis of atopic dermatitis present for at least 3 months
- At least 3 major criteria (such as itching, typical rash patterns, chronic dermatitis, or personal/family history of atopy)
- At least 3 minor criteria (such as dry skin, skin-test reactivity, early onset, or recurrent conjunctivitis)
- Eczema Area and Severity Index (EASI) score greater than 5 and/or Investigator's Global Assessment (IGA) score of 1 or more at enrollment
- Sexually active participants of childbearing potential must agree to use adequate contraception during and 30 days after treatment
- Willing and able to comply with study visits and procedures
- Ability to provide informed consent or assent
- Willingness to perform virtual visits
You will not qualify if you...
- Use of systemic immunosuppressive or immunomodulating drugs within 4 weeks before baseline
- Use of topical steroids, biologics, JAK inhibitors, PDE4 inhibitors, or certain emollients initiated within 12 weeks before baseline
- Use of phototherapy or photochemotherapy for atopic dermatitis within 4 weeks before baseline
- Active infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks before baseline
- Superficial skin infection needing topical treatment within 1 week before baseline
- History or suspicion of immunosuppression or immunodeficiency
- Presence of an indwelling central line
- Living with someone who has immunosuppression or an indwelling central line
- Any significant lab, medical history, or exam findings increasing risk
- Pregnancy or breastfeeding
- Females menstruating irregularly or not within 6 weeks prior to screening unless using long-term contraceptives
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 14 weeks
Participants apply the topical formulation of Roseomonas mucosa combined with ground cardamom seeds or placebo 2 to 3 times per week for active treatment of atopic dermatitis.
Weekly visits during treatment for assessments
Follow-up
Duration - 14 weeks
Participants stop active treatment and are followed to assess the lasting effects of the treatment on atopic dermatitis symptoms.
Visits at mid-follow-up (Week 21) and study completion (Week 28)
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Loading map...
Research Team
J
Jodi L Blake, R.N.
I
Ian A Myles, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Clinical efficacy of fecal microbial transplantation treatment in adults with moderate-to-severe atopic dermatitis.
Jacob Mashiah, Tal Karady, Naomi Fliss-Isakov...
https://pubmed.ncbi.nlm.nih.gov/34931478Therapeutic responses to Roseomonas mucosa in atopic dermatitis may involve lipid-mediated TNF-related epithelial repair.
Ian A Myles, Carlo R Castillo, Kent D Barbian...
https://pubmed.ncbi.nlm.nih.gov/32908007First-in-human topical microbiome transplantation with Roseomonas mucosa for atopic dermatitis.
Ian A Myles, Noah J Earland, Erik D Anderson...
https://pubmed.ncbi.nlm.nih.gov/29720571Development of a human skin commensal microbe for bacteriotherapy of atopic dermatitis and use in a phase 1 randomized clinical trial.
Teruaki Nakatsuji, Tissa R Hata, Yun Tong...
https://pubmed.ncbi.nlm.nih.gov/33619370Diisocyanates influence models of atopic dermatitis through direct activation of TRPA1.
Manoj Yadav, Prem Prashant Chaudhary, Brandon N D'Souza...
https://pubmed.ncbi.nlm.nih.gov/36877675Exposure to isocyanates predicts atopic dermatitis prevalence and disrupts therapeutic pathways in commensal bacteria.
Jordan Zeldin, Prem Prashant Chaudhary, Jacquelyn Spathies...
https://pubmed.ncbi.nlm.nih.gov/36608129