Health Canada Licenses Probiotical’s PROBIAL DERM® for Eczema and Atopic Dermatitis Claims

Eczema and Atopic Dermatitis (AD) is thought to affect as many as 10% of adults worldwide and represents a debilitating condition for many.1 It can result in a lower quality of life, and reports link it with social avoidance, limited lifestyle and impacted activities.2

Some studies have found a positive effect of probiotic supplementation on eczema and AD, but identifying which products are beneficial can prove difficult for consumers.

Now, Health Canada has licensed Probiotical’s probiotic supplement, PROBIAL DERM®, for functional claims related to its efficacy in improving eczema and AD symptoms. The product consisting of two bacterial strains Bifidobacterium breve BR03 (DSM 16604) and Ligilactobacillus salivarius LS01 (DSM 22775) was specifically developed to address dermatological allergic diseases.

Claims

The granted license will allow companies selling in Canada who use PROBIAL DERM® in their product to make the following claims:

  • Helps improve the symptoms of and provides relief from atopic dermatitis.
  • Helps improve the symptoms of and provides relief from eczema.
  • Clinically shown to help reduce symptoms of eczema and atopic dermatitis.
  • Helps provide relief from symptoms associated with eczema.
  • Helps provide relief from symptoms associated with atopic dermatitis.
  • Could promote a favourable gut flora.
  • Source of Probiotics.

This key breakthrough will ensure Probiotical’s customers can communicate the beneficial effects of PROBIAL DERM® to their consumers, enabling them to make informed choices about the products they use to improve their eczema and AD symptoms.

“Health Canada’s approval reflects our commitment to science,”

said Marco Pane, Chief Scientific Officer at Probiotical.

“PROBIAL DERM® goes beyond just addressing the symptoms of eczema and atopic dermatitis – it also supports overall well-being and quality of life. With strains like LS01 and BR03, which show promise in other skin conditions like chronic spontaneous urticaria and scalp rosacea, we are learning more about the role probiotics can play in improving skin health. We are proud of this achievement, and it drives us to keep pushing forward in developing probiotic solutions that truly make a positive impact on people’s lives.”

Clinical Studies

One study of PROBIAL DERM® in 48 adults with AD found that 3-month treatment led to significantly improved SCORAD index and Dermatology Life Quality Index (DLQI) scores. Additionally, treatment led to decreased immune activation (measured by an improved Th1:Th2 ratio) and reduced microbial translation (as measured by decreased LPS plasma concentration), suggesting a restoration of gut barrier function – a mechanism crucial for managing skin conditions such as eczema and AD. All changes in this study persisted following a 2-month suspension and were not observed in the placebo group.3

As well as showing efficacy in adults, PROBIAL DERM® has demonstrated clinical efficacy in paediatric populations. One study of 107 children, median age 7, with mild/moderate AD, found that 3 months of supplementation with PROBIAL DERM® led to clinical improvement (as measured by SCORAD score) and a reduction in the number of AD relapses. This benefit also persisted 2 months after treatment.4

The efficacy of PROBIAL DERM® has been partly attributed to its immunomodulatory properties. The probiotic combination has been shown to modulate immune responses, particularly by increasing IL-10 production. B. breve BR03 helps maintaining a balanced immune response, and in combination with L. salivarius LS01, it further enhances immunomodulatory effects, particularly by increasing IL-10 production while reducing pro-inflammatory cytokines such as IL-13 and IL-17. This suggests a synergistic effect in managing immune responses, which can be particularly beneficial in allergic conditions, especially in reducing the skin inflammation typical in AD patients.

In addition, LS01 demonstrated strong antipathogenic properties against Staphylococcus aureus, a common skin pathogen linked with the exacerbation of eczema symptoms, and possesses antioxidant activity. LS01 has also shown the ability to modulate gut microbiota in AD patients, which may further support skin health.

The Future

Moreover, PROBIAL DERM® has been explored for other dermatological and allergic conditions, such as chronic spontaneous urticaria and scalp rosacea, underscoring the potential broad applications of this probiotic combination in supporting skin health.

“We are excited about the future,”

Pane added.

“We believe there is so much more we can do by exploring probiotics and postbiotics for other skin conditions. This is just the beginning, and we are eager to keep finding new ways to improve skin health and the lives of patients who suffer from these challenging conditions.”

About Probiotical

Probiotical originated in 1985 from ALCE, Italian leader in the production of lactic acid bacteria for the dairy industry. Our plant is the first worldwide designed exclusively for the research and production of probiotic micro-organisms.
With core businesses in Europe, America and Asia, Probiotical is the partner of choice for companies seeking high quality, customized, safe, effective and stable probiotic and synbiotic products.

Probiotical offers a broad portfolio of allergen-free, lyophilized or microencapsulated strains supported by extensive characterization and clinical studies. Besides producing bulk ingredients, special attention is dedicated to probiotic finished products with guaranteed efficacy during all the shelf-life.


Citations
  1. International League of Dermatological Societies (ILDS) (2022); Global Report on Atopic Dermatitis 2022
  2. Silverberg, J.I. et al. (2018); ‘Patient burden and quality of life in atopic dermatitis in US adults’
  3. Iemoli E. et al. (2012); ‘Probiotics reduce gut microbial translocation and improve adult atopic dermatitis’
  4. Licari A. et al. (2016); ‘Efficacia clinica di Lactobacillus salivarius LS01 e Bifidobacterium breve BR03 in pazienti pediatrici affetti da dermatite atopica’