Topical Bacteria + Cardamom for Eczema
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
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
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.
12345Is 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.
56789How 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.
610111213Eligibility 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.
+7 more
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.
+7 more
Trial 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)
Participant Groups
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.
2Treatment groups
Active Control
Placebo Group
Group I: ActiveActive Control1 Intervention
Roseomonas and Cardamom seeds
Group II: PlaceboPlacebo Group1 Intervention
Sucrose
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
National Institutes of Health Clinical CenterBethesda, MD
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Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
References
Double-blind crossover trial with oral sodium cromoglycate in children with atopic dermatitis due to food allergy. [2013]Thirty-one children with atopic dermatitis, aged 6 months to 10 years, were selected for this trial. All had historical, clinical, and laboratory evidences that allergy to food was the cause of exacerbations of eczema. Either oral sodium cromoglycate (SCG) or a matching placebo was administered orally for 8 weeks, followed by the alternative treatment for a further 8-week period. During the first 4 weeks of each treatment period, patients remained on an exclusion diet. During the second 4 weeks, the offending food(s) was reintroduced into the diet. The severity of the eczema and the changes in severity as a result of diet or challenge were measured both by the clinician (using body diagrams) and by parents (using a daily diary card). Analysis of the clinician's scoring and the patient's diary card scores demonstrated a statistically significant difference in favour of SCG, especially in the group where the placebo preceded the active treatment. Sodium cromoglycate does seem to reduce the exacerbations of atopic dermatitis caused by food allergens.
Proof of efficacy of Kamillosan(R) cream in atopic eczema. [2022]Kamillosan(R) cream contains chamomile extract as active principle manufactured from the chamomile sort Manzana which is rich in active principles and has been proved not to exhibit a chamomile-related allergen potential. For this reason Kamillosan(R) cream is suited for local therapy of atopic eczema. In a partially double-blind, randomized study carried out as a half-side comparison, Kamillosan(R) cream was tested vs. 0.5% hydrocortisone cream and the vehicle cream as placebo in patients suffering from medium-degree atopic eczema. After a 2-week treatment Kamillosan(R) cream showed a mild superiority towards 0.5% hydrocortisone and a marginal difference as compared to placebo.
Validation of Botanical Treatment Efficiency for Adults and Children Suffering from Mild to Moderate Atopic Dermatitis [2020]Objective: The study was conducted to determine the efficiency of the botanicals combination incorporated in the Kamedis Eczema Therapy Cream (the tested product) for adults and children suffering from mild to moderate Atopic Dermatitis. Design: The study designed as an interventional, multi-center, double-blind, randomized, controlled study. Setting: Subjects were evenly randomly divided into three treatment groups: tested product, vehicle, and comparator. The vehicle used was the identical tested product without the botanical combination while the comparator was a leading OTC brand in the US market. All three above groups used a similar Kamedis wash for the body and face following by one of the three randomized treatment creams for the affected areas on the face and body. Participants: One hundred and eight (108) subjects with uncomplicated, stable, mild to moderate atopic dermatitis recruited and qualified for the study; 71 females and 37 males, age 3 to 73. Measurements: The investigator assessed the severity of each subject using the Investigator Global Assessment (IGA) and affected body surface area (BSA) at each of the visit days 0, 7, 14, and 28. Results: The tested product demonstrated an improvement in IGA and BSA over the vehicle at every visit across treatment time, proving the validation that the botanical product is much more effective and beneficial than the same product without the botanicals. The tested product as well as the comparator reached exactly the same percentage, 34%, of 'clear' IGA subjects of the enrolled subjects, presenting advantage over the vehicle. The BSA improvement comparison analysis of the tested product over the vehicle yielded statistically significant P value of 0.0369. Conclusion: The study results approve and validate that the botanical combination is the key factor for the efficacy and improvement of the AD symptoms within this study population. J Drugs Dermatol. 2019;18(6):557-561.
Reliéva, a Mahonia aquifolium extract for the treatment of adult patients with atopic dermatitis. [2007]This clinical study was conducted to determine the efficacy and safety of Reliéva cream in adult patients with atopic dermatitis (eczema). This was an open-label trial in 42 patients with atopic dermatitis treated for 12 weeks with Reliéva cream (a homeopathic product containing Psorberine, a proprietary Mahonia aquifolium extract). Efficacy and safety was assessed using Eczema Area and Severity Index scores and a Subject Reported Evaluation of Treatment. The results showed significant (P
A new flavonoid from Stellera chamaejasme L., stechamone, alleviated 2,4-dinitrochlorobenzene-induced atopic dermatitis-like skin lesions in a murine model. [2020]Stellera chamaejasme L. (family Thymelaeaceae), also known as 'Langdu', has been traditionally used to treat of skin-related diseases, such as, psoriasis and skin ulcers. The aim of this study was to identify the biologically active component of S. chamaejasme and evaluate its preventive effects on IL-4 and mast cell degranulation in RBL-2H3 cells and on the development of atopic dermatitis (AD) in 2,4-dinitrochlorobenzene (DNCB)-treated SKH-1 hairless mice. A novel flavonoid, genkwanin 5-O-xylosyl(1 → 2)glucoside (named stechamone), and three known compounds (umbelliferone, luteolin, and luteolin-7-O-glucoside) were isolated from the aerial parts of S. chamaejasme using chromatographic methods. Of these four compounds, stechamone most potently inhibited IL-4 production and mast cell degranulation in RBL-2H3 cells. Topical application of 0.5% stechamone improved atopic skin symptoms, including, erythema (redness), pruritus (itching), exudation (weeping), excoriation (peeling), and lichenification (skin thickening) in DNCB-treated AD mice by accelerating skin barrier recovery function and suppressing inflammatory cell infiltration. In addition, stechamone attenuated DNCB-induced increases in IL-4 (an inflammatory TH2 cytokine) expression and in serum IgE levels in our murine model of AD. DNCB induced AD-like skin lesions, but treatment with stechamone exhibited strong anti-atopic activity by regulating skin barrier function and reducing inflammatory responses. The results obtained suggest stechamone is a potential anti-atopic agent and treatment for skin inflammatory diseases.
Allergic contact dermatitis from cardamom. [2019]A case is presented of a confectioner with a chronic hand dermatitis and positive patch test reactions to cardamom and certain terpenoid compounds present in the dried ripe seeds of cardamom. Cardamom is a popular traditional flavouring agent for baked goods and confectionery. Dermatitis from skin exposure to cardamom has to the best of our knowledge not been reported. We report one case of allergic contact dermatitis to cardamom elicited by terpenes present in the seeds.
Cardamonin Inhibits Oxazolone-Induced Atopic Dermatitis by the Induction of NRF2 and the Inhibition of Th2 Cytokine Production. [2020]The skin is constantly exposed to various types of chemical stresses that challenge the immune cells, leading to the activation of T cell-mediated hypersensitivity reactions including atopic dermatitis. Previous studies have demonstrated that a variety of natural compounds are effective against development of atopic dermatitis by modulating immune responses. Cardamonin is a natural compound abundantly found in cardamom spices and many other medicinal plant species. In the present study, we attempted to examine whether cardamonin could inhibit oxazolone-induced atopic dermatitis in vivo. Our results show that topical application of cardamonin onto the ear of mice suppressed oxazolone-induced inflammation in the ear and hyperplasia in the spleen. Cardamonin also inhibited oxazolone-induced destruction of connective tissues and subsequent infiltration of mast cells into the skin. In addition, we found that the production of Th2 cytokines is negatively regulated by NRF2, and the induction of NRF2 by cardamonin contributed to suppressing oxazolone-induced Th2 cytokine production and oxidative damages in vivo. Together, our results demonstrate that cardamonin is a promising natural compound, which might be effective for treatment of atopic dermatitis.
Protective Role of Phenolic Compounds from Whole Cardamom (Elettaria cardamomum (L.) Maton) against LPS-Induced Inflammation in Colon and Macrophage Cells. [2023]The chemical profiling of phenolic and terpenoid compounds in whole cardamom, skin, and seeds (Elettaria cardamomum (L.) Maton) showed 11 phenolics and 16 terpenoids, many of which are reported for the first time. Herein, we report the anti-inflammatory properties of a methanolic extract of whole cardamom in colon and macrophage cells stimulated with an inflammatory bacteria lipopolysaccharide (LPS). The results show that cardamom extracts lowered the expression of pro-inflammatory genes NFkβ, TNFα, IL-6, and COX2 in colon cells by reducing reactive oxygen species (ROS) while not affecting LXRα. In macrophages, cardamom extracts lowered the expression of pro-inflammatory genes NFkβ, TNFα, IL-6, and COX2 and decreased NO levels through a reduction in ROS and enhanced gene expression of nuclear receptors LXRα and PPARγ. The cardamom extracts in a range of 200-800 μg/mL did not show toxicity effects in colon or macrophage cells. The whole-cardamom methanolic extracts contained high levels of phenolics compounds (e.g., protocatechuic acid, caffeic acid, syringic acid, and 5-O-caffeoylquinic acid, among others) and are likely responsible for the anti-inflammatory and multifunctional effects observed in this study. The generated information suggests that cardamom may play a protective role against low-grade inflammation that can be the basis of future in vivo studies using mice models of inflammation and associated chronic diseases.
Anti-hypercholesterolemic influence of the spice cardamom (Elettaria cardamomum) in experimental rats. [2017]Label="BACKGROUND" NlmCategory="BACKGROUND">Cardamom (Elettaria cardamomum) is an aromatic seed spice grown extensively in India and used as a flavoring in sweets. In this study, the anti-hypercholesterolemic effect of cardamom was evaluated in Wistar rats by inducing hypercholesterolemia with a high-cholesterol diet for 8 weeks. Dietary interventions were made with (a) cardamom powder (50 g kg-1 ), (b) cardamom oil (3 g kg-1 , equivalent to 50 g kg-1 cardamom) and (c) de-oiled cardamom powder (50 g kg-1 ).
First-in-human topical microbiome transplantation with Roseomonas mucosa for atopic dermatitis. [2019]The underlying pathology of atopic dermatitis (AD) includes impaired skin barrier function, susceptibility to Staphylococcus aureus skin infection, immune dysregulation, and cutaneous dysbiosis. Our recent investigation into the potential role of Gram-negative skin bacteria in AD revealed that isolates of one particular commensal, Roseomonas mucosa, collected from healthy volunteers (HVs) improved outcomes in mouse and cell culture models of AD. In contrast, isolates of R. mucosa from patients with AD worsened outcomes in these models. These preclinical results suggested that interventions targeting the microbiome could provide therapeutic benefit for patients with AD. As a first test of this hypothesis in humans, 10 adult and 5 pediatric patients were enrolled in an open-label phase I/II safety and activity trial (the Beginning Assessment of Cutaneous Treatment Efficacy for Roseomonas in Atopic Dermatitis trial; BACTERiAD I/II). Treatment with R. mucosa was associated with significant decreases in measures of disease severity, topical steroid requirement, and S. aureus burden. There were no adverse events or treatment complications. We additionally evaluated differentiating bacterial metabolites and topical exposures that may contribute to the skin dysbiosis associated with AD and/or influence future microbiome-based treatments. These early results support continued evaluation of R. mucosa therapy with a placebo-controlled trial.
Lactobacillus rhamnosus cell lysate in the management of resistant childhood atopic eczema. [2022]The number of children suffering from atopic eczema has increased over the past 30 years especially in children between the ages of 2 and 5 years. These is a significant group of eczematous children that are resistant to standard therapy. Babies and children with eczema suffer pain, irritation and disfigurement from the dermatitis. In this study, we have followed 14 cases of pediatric patients (ages of 8 months to 64 months) with a history of resistant eczema for a period of at least six months. All of these children received 300 mg to 500 mg standardized Lactobacillus rhamnosus cell lysate daily as an immunobiotic supplement. The results of this open label non-randomized clinical observation showed a substantial improvement in quality of life, skin symptoms and day- and nighttime irritation scores in children with the supplementation of Lactobacillus rhamnosus lysate. There were no intolerance or adverse reactions observed in these children. Lactobacillus rhamnosus cell lysate may thus be used as a safe and effective immunobiotic for the treatment and prevention of childhood eczema and possible other types of atopy (allergic diseases).
Therapeutic responses to Roseomonas mucosa in atopic dermatitis may involve lipid-mediated TNF-related epithelial repair. [2021]Dysbiosis of the skin microbiota is increasingly implicated as a contributor to the pathogenesis of atopic dermatitis (AD). We previously reported first-in-human safety and clinical activity results from topical application of the commensal skin bacterium Roseomonas mucosa for the treatment of AD in 10 adults and 5 children older than 9 years of age. Here, we examined the potential mechanism of action of R. mucosa treatment and its impact on children with AD less than 7 years of age, the most common age group for children with AD. In 15 children with AD, R. mucosa treatment was associated with amelioration of disease severity, improvement in epithelial barrier function, reduced Staphylococcus aureus burden on the skin, and a reduction in topical steroid requirements without severe adverse events. Our observed response rates to R. mucosa treatment were greater than those seen in historical placebo control groups in prior AD studies. Skin improvements and colonization by R. mucosa persisted for up to 8 months after cessation of treatment. Analyses of cellular scratch assays and the MC903 mouse model of AD suggested that production of sphingolipids by R. mucosa, cholinergic signaling, and flagellin expression may have contributed to therapeutic impact through induction of a TNFR2-mediated epithelial-to-mesenchymal transition. These results suggest that a randomized, placebo-controlled trial of R. mucosa treatment in individuals with AD is warranted and implicate commensals in the maintenance of the skin epithelial barrier.
[Probiotics and prebiotics for the prevention and treatment of atopic eczema]. [2018]The rapid increase of atopic diseases, particularly in western industrialized countries, demands comprehensive and cost-effective primary prevention. Existing findings regarding the use of probiotic lactic acid bacteria for the prevention of atopic eczema are promising. Therapeutic use appears to be more promising for infants with mild to moderate skin lesions and elevated immunoglobulin E levels than for older patients without any sensitization. Depending on the original bacterial count, prebiotics such as fructooligosaccharides and galactooligosaccharides cause an increase of bifidobacteria within the colon. The benefit of this increase in bifidobacteria in allergic diseases is unclear. In patients with atopic eczema a correlation was shown between the amount of bifidobacteria and the severity of atopic eczema.