Topical Bacteria + Cardamom for Eczema

Overseen By Ian A Myles, M.D.

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must not be taking: Immunosuppressives, Phototherapy, Biologics, others

Disqualifiers: Active infection, Immunosuppression, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 14 weeks

240 Participants Needed

Trial Summary

What is the purpose of this trial?

Background: Atopic dermatitis (AD), also called eczema, is a chronic skin condition. AD can make skin dry and itchy, and sometimes it can lead to serious health problems, such as asthma, food allergies, eye infections, and sleep problems. No cure exists for AD. Researchers know that people with AD have different kinds of harmless bacteria on their skin than do people without AD. They want to see if adding a harmless bacteria (Roseomonas mucosa) to the skin can help people with AD. Objective: To test a skin treatment that contains R. mucosa and ground cardamom seeds in people with AD. Eligibility: People aged 2 years and older with AD. Design: All study visits will be remote. Participants will have 5 visits over about 7 months. Participants will be screened. Researchers will review their AD and medical history. Participants will receive a study product in the mail. The product comes as a powder in single-use packets. Participants will be shown how to mix the powder with water in a single-use spray vial. They will spray the solution onto their skin 2 to 3 times per week for 14 weeks. Half of participants will receive the study powder. Half will receive a placebo; the placebo looks just like the study powder but contains no bacteria. They will not know which one they have. During 3 study visits, participants will take a skin swab. They will receive supplies in the mail to rub a cotton swab on their skin and mail it back to the researchers. Participants may opt to have pictures taken of their AD. Participants will fill out 4 online questionnaires.

Will I have to stop taking my current medications?

The trial requires that you stop certain medications before starting. You must not have used immunosuppressive drugs, phototherapy, or certain topical treatments for a specified period before the trial begins. Check with the trial team to see if your current medications are affected.

What evidence supports the effectiveness of the treatment using Topical Bacteria + Cardamom for Eczema?

Research on other botanical treatments, like chamomile and Mahonia aquifolium, shows they can help with eczema by reducing inflammation and improving skin condition. This suggests that natural ingredients, like cardamom, might also be beneficial for eczema. ^{1 2 3 4 5}

Is the combination of topical bacteria and cardamom safe for treating eczema?

Cardamom has been shown to have anti-inflammatory properties and did not show toxicity in cell studies, but there is a case of allergic skin reaction to cardamom in one person. This suggests that while generally safe, some individuals may experience allergic reactions. ^{5 6 7 8 9}

How does the treatment with Topical Bacteria + Cardamom for Eczema differ from other treatments?

This treatment is unique because it uses a combination of Roseomonas mucosa, a beneficial skin bacterium, and cardamom, which may help improve skin health by restoring the natural balance of skin bacteria and reducing harmful bacteria like Staphylococcus aureus. Unlike traditional treatments that often rely on steroids, this approach targets the skin's microbiome to enhance the skin barrier and reduce inflammation. ^{6 10 11 12 13}

Research Team

Ian A Myles, M.D.

Principal Investigator

National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria

This trial is for people aged 2 years and older with atopic dermatitis (AD), also known as eczema. Participants must be willing to do virtual visits, speak English, have a primary care provider nearby, and use contraception if of childbearing potential. They should not have used certain AD treatments recently or have infections needing systemic treatment.

Inclusion Criteria

Have a documented primary care provider near residence

Fluency in English (applicable to participant or caregiver who will be answering questionnaires)

I have been diagnosed with atopic dermatitis for at least 3 months.

Exclusion Criteria

Any clinically significant laboratory, history, or exam findings that, in the investigator's opinion, would suggest an increased risk to the participant.

Self-reported pregnancy or breastfeeding.

I haven't used certain immune-affecting drugs or light therapy for my skin condition in the last 4 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (remote)

Treatment

Participants receive the study product, applying it topically 2-3 times per week for 14 weeks

14 weeks

3 visits (remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 weeks

1 visit (remote)

Treatment Details

Interventions

• Cardamom seeds
• Placebo (sucrose)
• Roseomonas mucosa

Trial Overview The study tests a skin treatment combining Roseomonas mucosa bacteria and ground cardamom seeds against a placebo. Over about 7 months, participants will apply the mixture or placebo to their skin several times per week and complete online questionnaires.

Participant Groups

Group I: Active Active Control 1 Intervention

Roseomonas and Cardamom seeds

Group II: Placebo Placebo Group 1 Intervention

Sucrose

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Findings from Research

In a trial involving 31 children with atopic dermatitis, oral sodium cromoglycate (SCG) significantly reduced eczema severity compared to a placebo, particularly when the placebo was given first.

The study suggests that SCG can effectively manage eczema flare-ups triggered by food allergies, as evidenced by both clinician assessments and parent-reported diary scores over a total treatment duration of 16 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double-blind crossover trial with oral sodium cromoglycate in children with atopic dermatitis due to food allergy. Businco, L., Benincori, N., Nini, G., et al.[2013]

Kamillosan(R) cream, which contains chamomile extract, was found to be effective for treating medium-degree atopic eczema, showing mild superiority over 0.5% hydrocortisone cream in a randomized half-side comparison study.

The study demonstrated that Kamillosan(R) cream has a low allergen potential, making it a safe option for local therapy in patients with atopic eczema, with results observed after a 2-week treatment period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proof of efficacy of Kamillosan(R) cream in atopic eczema. Patzelt-Wenczler, R., Ponce-Pöschl, E.[2022]

The Kamedis Eczema Therapy Cream, which contains a botanical combination, significantly improved symptoms of mild to moderate Atopic Dermatitis compared to a vehicle cream without botanicals, as shown by better scores in the Investigator Global Assessment (IGA) and affected body surface area (BSA) across all treatment visits.

Both the Kamedis cream and a leading OTC comparator achieved the same percentage of subjects rated as 'clear' (34%), indicating that the botanical formulation is as effective as a well-known treatment while providing additional benefits over the vehicle cream.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of Botanical Treatment Efficiency for Adults and Children Suffering from Mild to Moderate Atopic Dermatitis Draelos, ZD., Traub, M., Gold, MH., et al.[2020]

In a 12-week open-label trial involving 42 adult patients with atopic dermatitis, Reliéva cream demonstrated significant improvements in Eczema Area and Severity Index scores compared to baseline, indicating its efficacy in treating eczema.

Patients reported substantial benefits in terms of effectiveness, itching relief, and overall appearance of their skin after using Reliéva cream, suggesting it is both safe and effective for managing atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliéva, a Mahonia aquifolium extract for the treatment of adult patients with atopic dermatitis. Donsky, H., Clarke, D.[2007]

A novel flavonoid called stechamone, isolated from Stellera chamaejasme, was found to significantly inhibit IL-4 production and mast cell degranulation in laboratory cells, indicating its potential as an anti-inflammatory agent.

Topical application of stechamone improved symptoms of atopic dermatitis in mice, such as redness and itching, by enhancing skin barrier recovery and reducing inflammation, suggesting it could be an effective treatment for skin inflammatory diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new flavonoid from Stellera chamaejasme L., stechamone, alleviated 2,4-dinitrochlorobenzene-induced atopic dermatitis-like skin lesions in a murine model. Jo, BG., Park, NJ., Jegal, J., et al.[2020]

A case study of a confectioner revealed chronic hand dermatitis caused by an allergic reaction to cardamom, specifically to terpenoid compounds found in the seeds.

This is the first reported case of allergic contact dermatitis from skin exposure to cardamom, highlighting the need for awareness of potential allergens in common flavoring agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allergic contact dermatitis from cardamom. Mobacken, H., Fregert, S.[2019]

Topical application of cardamonin significantly reduced inflammation and tissue damage in a mouse model of atopic dermatitis, indicating its potential as a treatment for this condition.

Cardamonin works by activating the NRF2 pathway, which helps to suppress harmful Th2 cytokine production and oxidative stress, contributing to its anti-inflammatory effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardamonin Inhibits Oxazolone-Induced Atopic Dermatitis by the Induction of NRF2 and the Inhibition of Th2 Cytokine Production. Yoo, OK., Choi, WJ., Keum, YS.[2020]

A methanolic extract of whole cardamom demonstrated significant anti-inflammatory properties by reducing the expression of pro-inflammatory genes in colon and macrophage cells without showing any toxicity at concentrations between 200-800 μg/mL.

The high levels of phenolic compounds in cardamom, such as protocatechuic acid and caffeic acid, are likely responsible for its anti-inflammatory effects, suggesting that cardamom could help protect against low-grade inflammation and may warrant further in vivo studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protective Role of Phenolic Compounds from Whole Cardamom (Elettaria cardamomum (L.) Maton) against LPS-Induced Inflammation in Colon and Macrophage Cells. Sreedharan, S., Nair, V., Cisneros-Zevallos, L.[2023]

In a study with Wistar rats fed a high-cholesterol diet for 8 weeks, cardamom oil significantly reduced total cholesterol by 31% and low-density lipoprotein (LDL) cholesterol by 44%, indicating its strong anti-hypercholesterolemic effects.

Cardamom oil also improved heart health by lowering triglycerides by 42% and enhancing antioxidant enzyme activity, suggesting it may have cardioprotective properties without affecting overall food consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-hypercholesterolemic influence of the spice cardamom (Elettaria cardamomum) in experimental rats. Nagashree, S., Archana, KK., Srinivas, P., et al.[2017]

In a phase I/II trial involving 15 patients (10 adults and 5 children) with atopic dermatitis, treatment with the commensal bacterium Roseomonas mucosa led to significant improvements in disease severity and reduced reliance on topical steroids, with no reported adverse events.

The study suggests that targeting the skin microbiome, particularly with beneficial bacteria like R. mucosa, could be a promising therapeutic approach for managing atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-human topical microbiome transplantation with Roseomonas mucosa for atopic dermatitis. Myles, IA., Earland, NJ., Anderson, ED., et al.[2019]

In a study of 14 pediatric patients aged 8 to 64 months with resistant eczema, daily supplementation with 300 to 500 mg of Lactobacillus rhamnosus cell lysate led to significant improvements in quality of life and skin symptoms over at least six months.

The treatment was well-tolerated with no adverse reactions reported, suggesting that Lactobacillus rhamnosus lysate is a safe and effective option for managing childhood eczema and potentially other allergic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lactobacillus rhamnosus cell lysate in the management of resistant childhood atopic eczema. Hoang, BX., Shaw, G., Pham, P., et al.[2022]

In a study involving 15 children under 7 years old with atopic dermatitis (AD), treatment with the commensal bacterium Roseomonas mucosa led to significant improvements in disease severity, skin barrier function, and reduced reliance on topical steroids, with no severe adverse events reported.

The mechanism of action appears to involve the production of sphingolipids and cholinergic signaling, which may enhance skin health by promoting epithelial-to-mesenchymal transition, suggesting that further randomized trials are needed to explore R. mucosa as a treatment for AD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic responses to Roseomonas mucosa in atopic dermatitis may involve lipid-mediated TNF-related epithelial repair. Myles, IA., Castillo, CR., Barbian, KD., et al.[2021]

Probiotic lactic acid bacteria show promise in preventing atopic eczema, particularly in infants with mild to moderate skin lesions and high immunoglobulin E levels, suggesting a targeted approach for effective prevention.

The relationship between bifidobacteria levels and the severity of atopic eczema indicates that while prebiotics can increase bifidobacteria, their specific benefits in allergic diseases remain uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Probiotics and prebiotics for the prevention and treatment of atopic eczema]. Bunselmeyer, B.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Double-blind crossover trial with oral sodium cromoglycate in children with atopic dermatitis due to food allergy. [2013]

2. England pubmed.ncbi.nlm.nih.gov

Proof of efficacy of Kamillosan(R) cream in atopic eczema. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Validation of Botanical Treatment Efficiency for Adults and Children Suffering from Mild to Moderate Atopic Dermatitis [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Reliéva, a Mahonia aquifolium extract for the treatment of adult patients with atopic dermatitis. [2007]

5. Netherlands pubmed.ncbi.nlm.nih.gov

A new flavonoid from Stellera chamaejasme L., stechamone, alleviated 2,4-dinitrochlorobenzene-induced atopic dermatitis-like skin lesions in a murine model. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Allergic contact dermatitis from cardamom. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Cardamonin Inhibits Oxazolone-Induced Atopic Dermatitis by the Induction of NRF2 and the Inhibition of Th2 Cytokine Production. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Protective Role of Phenolic Compounds from Whole Cardamom (Elettaria cardamomum (L.) Maton) against LPS-Induced Inflammation in Colon and Macrophage Cells. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Anti-hypercholesterolemic influence of the spice cardamom (Elettaria cardamomum) in experimental rats. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

First-in-human topical microbiome transplantation with Roseomonas mucosa for atopic dermatitis. [2019]

11. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Lactobacillus rhamnosus cell lysate in the management of resistant childhood atopic eczema. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Therapeutic responses to Roseomonas mucosa in atopic dermatitis may involve lipid-mediated TNF-related epithelial repair. [2021]

13. Germany pubmed.ncbi.nlm.nih.gov

[Probiotics and prebiotics for the prevention and treatment of atopic eczema]. [2018]