Emerging Evidence in the Dietary Management of Eczema With Probiotics

This article was sponsored by Florajen^® Eczema.

Atopic dermatitis (AD), commonly referred to as eczema, is a common chronic inflammatory skin condition characterized by its hallmark feature of pruritus (itching), which causes painful skin irritation, soreness, and difficulty sleeping.¹ Although symptoms often first present during childhood, AD is recurrent and can persist into adulthood, requiring long-term management.^1-3 Patients with AD can experience overall impairments to daily activities and emotional comorbidities as result of their condition.^1,2

AD can be classified by severity based on objective clinical observations and subjective patient reports on itching and sleep impairment. Clinical manifestations can include inflamed, dry, scaly, oozing, or crusty skin.¹ Symptoms typically fluctuate between flares (periods of skin worsening) and dormancy with treatment.³

MANAGEMENT STRATEGIES

The prevention and management of flares can be a challenge for many patients. It may require a combination of nonpharmacologic (eg, IgE-mediated allergy avoidance and daily moisturizers) and pharmacologic (eg, topical corticosteroids, topical calcineurin inhibitors, oral antihistamines) strategies, depending on severity.^3,4

OTC and prescription topical corticosteroids are a mainstay option for the temporary relief and prevention of flares; however, long-term use for more than twice-weekly application is not recommended.^3,4 Prolonged daily use is associated with risks of corticosteroid withdrawal after discontinuation.⁵ Other treatment-related adverse effects (AEs) of topical corticosteroids can include telangiectasia, striae, skin atrophy, and systemic effects such as suppression of the hypothalamic-pituitary-adrenal axis, which can be more pronounced in children due to their higher body surface to weight ratio.¹

There is a need for safe and effective complementary strategies that can provide an alternative option to topical corticosteroid treatments to help patients achieve improvements in eczema severity and clear skin outcomes. Pharmacists have an opportunity to increase awareness of the complementary options available, such as Florajen^® Eczema, a medical food that contains a unique blend of probiotics that have been specifically studied for the dietary management of eczema.^6,7

IMBALANCED MICROBIOME IN AD PATHOGENESIS

Emerging evidence has highlighted the potential role for probiotics as a nutritional adjunctive management strategy to address gut microflora imbalances that may contribute to the pro-inflammatory state in AD.^7,8

A combination of factors involving genes, the immune system, and the environment can contribute to dysfunction of the skin barrier and immunity, causing the hallmark AD characteristics of red, itchy, and painful skin.¹ The exact mechanism is not fully understood; however, there appears to be an association between the gastrointestinal (GI) system and skin, called the gut-skin axis, in the development of AD.⁸

Changes in gut flora can compromise gut wall integrity and increase GI permeability, resulting in the passage of inflammatory products, bacteria, and toxins from the GI tract into the circulatory system. The presence of gut microbiota and their metabolites within the circulation can trigger an immune response, resulting in systemic inflammation. These components can also accumulate in the skin and disrupt normal epidermal barrier function.^8,9

Analyses of Bacterial Species in Patients With AD

Patients with AD have distinct differences in their gut microbiome composition that may contribute to disease manifestation.⁸ Compared with non-AD populations, those with AD have reduced levels of certain beneficial bacteria and their metabolites, such as short-chain fatty acid (SCFA)—producing bacteria (eg, Propionibacterium and Bifidobacterium).¹⁰ Certain SCFAs suppress inflammatory responses and help maintain gut barrier integrity; therefore, reduced levels of SCFA-producing bacteria may result in a pro-inflammatory state in the gut.⁹

Those with AD may have specific nutritional needs in order to balance their gut microbiome.⁹ Results from separate studies have shown elevated levels of Faecalibacterium prausnitzii in the general AD population, a higher prevalence of Clostridia species among children, greater colonization with Enterobacteriaceae in adults and infants, and a lack of bacterial diversity in infants with AD.⁸ Therefore, probiotics may help address gut microbiome imbalances.^7,8

Because different probiotic strains provide different health benefits, it is important to increase awareness of probiotic formulas that have clinical evidence supporting their use.

FLORAJEN® ECZEMA

Florajen^® Eczema is the first and only probiotic medical food available for the dietary management of eczema.

Each packet of this medical food contains 1 billion colony-forming-units of
3 probiotic strains: Bifidobacterium longum CECT 7347, Bifidobacterium lactis CECT 8145, and Lactobacillus casei CECT 9104. Florajen^® Eczema is intended to be used under the supervision of a health care professional.⁶

The effectiveness of the probiotic blend in Florajen^® Eczema was investigated in a 12-week, randomized, placebo-controlled clinical study of 50 children aged 4 to 17 years with moderate AD as assessed on the SCORing Atopic Dermatitis (SCORAD) index. Patients received topical methylprednisolone aceponate, a moisturizer, and an oral antihistamine in combination with either
Florajen^® Eczema or placebo once daily.⁷

Clinical Improvements in Eczema Severity

From baseline to 12 weeks of follow-up, patients in the probiotic group achieved an 83% reduction in overall eczema severity, as measured by a reduction in the SCORAD index score, compared with a 24% reduction in the placebo group (relative difference, −59%; 95% CI, −72% to −46%; P < .001). Moreover, 91% of patients in the probiotic group achieved clear or almost clear skin on the Investigator Global Assessment scale compared with 21% in the placebo group over the 12-week study period.^6,7

Reduction in Topical Corticosteroid Use

Over the study period, there was a significant reduction in topical corticosteroid use for the treatment of flares in the probiotic group compared with the placebo group at 161 versus 220 patient-days of use, respectively (odds ratio, 0.63;
95% CI, 0.51-0.78; P < .001).⁷

Findings from this clinical study suggest that the mixture of 3 probiotic strains in Florajen^® Eczema may be an effective adjuvant management option that can reduce overall eczema severity and the use of topical corticosteroids during flares.⁷ In a separate published review of probiotic strains for pediatric AD, the probiotic blend in Florajen^® Eczema was noted to reduce AD symptoms with “high certainty evidence.”¹¹

ROLE OF THE PHARMACIST

Eczema can be difficult to manage and may require a combination of strategies.^3,4 As accessible health care professionals, pharmacists have an important role in supporting the management of eczema from the pharmacy. For children and their caregivers, pharmacists may consider alternatives to topicals and recommend options that are easy to administer, appropriate for daily use, and eliminate AEs associated with topical corticosteroid use. When asked for a product recommendation, pharmacists can provide education on the different products available, including Florajen^® Eczema, highlighting its clinical effectiveness for flare management, skin clearance, and reduction in topical corticosteroid use.⁶

Along with other available probiotics, Florajen^® Eczema should be stored in the pharmacy refrigerator to maintain the product’s freshness and potency through its expiration date.⁶ Because Florajen^® Eczema is available behind the pharmacy counter, pharmacists have the opportunity to review the labeled information, counsel patients on key storage and administration information, and provide them with education and resources for Florajen^® Eczema that are available at florajen.com/professional.

REFERENCES

1. Eichenfield LF, Tom WL, Chamlin SL, et al. Guidelines of care for the management of atopic dermatitis: section 1: diagnosis and assessment of atopic dermatitis.
   J Am Acad Dermatol. 2014;70(2):338-351.doi:10.1016/j.jaad.2013.10.010
2. Chiesa Fuxench ZC, Block JK, Boguniewicz M, et al. Atopic Dermatitis in America study: a cross-sectional study examining the prevalence and disease burden of atopic dermatitis in the US adult population. J Invest Dermatol. 2019;139(3):583-590. doi:10.1016/j.jid.2018.08.028
3. Sidbury R, Tom WL, Bergman JN, et al. Guidelines of care for the management of atopic dermatitis: section 4: prevention of disease flares and use of adjunctive therapies and approaches. J Am Acad Dermatol. 2014;71(6):1218-1233. doi:10.1016/j.jaad.2014.08.038
4. Eichenfield LF, Tom WL, Berger TG, et al. Guidelines of care for the management of atopic dermatitis: section 2: management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014;71(1):116-132. doi:10.1016/j.jaad.2014.03.023
5. Education announcement: use of topical steroids for eczema.
   National Eczema Association. Updated April 14, 2015. Accessed February 3, 2021. https://nationaleczema.org/warnings-for-topical-steroids-eczema/
6. Florajen^® Eczema. Prescribing information. American Lifeline, Inc; 2021.
7. Navarro-López V, Ramírez-Bosca A, Ramón-Vidal D, et al. Effect of oral administration of a mixture of probiotic strains on SCORAD index and use of topical steroids in young patients with moderate atopic dermatitis: a randomized clinical trial. JAMA Dermatol. 2018;154(1):37-43. doi:10.1001/jamadermatol.2017.3647
8. Ellis SR, Nguyen M, Vaughn AR, et al. The skin and gut microbiome and its role in common dermatologic conditions. Microorganisms. 2019;7(11):550. doi:10.3390/microorganisms7110550
9. Salem I, Ramser A, Isham N, Ghannoum MA. The gut microbiome as a major regulator of the gut-skin axis. Front Microbiol. 2018;9:1459. doi:10.3389/fmicb.2018.01459
10. Reddel S, Del Chierico F, Quagliariello A, et al. Gut microbiota profile in children affected by atopic dermatitis and evaluation of intestinal persistence of a probiotic mixture.
    Sci Rep. 2019;9(1):4996. doi:10.1038/s41598-019-41149-6
11. Tan-Lim CSC, Esteban-Ipac NAR, Mantaring JBV 3rd, et al. Comparative effectiveness of probiotic strains for the treatment of pediatric atopic dermatitis: a systematic review and network meta-analysis. Pediatr Allergy Immunol. 2020. doi: 10.1111/pai.13305