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Efficacy of an adjuvant Lactobacillus rhamnosus formula in improving skin lesions as assessed by PASI in patients with plaque psoriasis from a university-affiliated, tertiary-referral hospital in São Paulo (Brazil): a parallel, double-blind, randomized clinical trial

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Abstract

Psoriasis is an inflammatory disease of the skin, characterized by erythematous plaques. It is rather common, affecting 2–4% of the population in western countries. Psoriasis’ etiology encompasses both genetic and environmental factors. Evidence suggests that the latter reflect the importance of changes in the microbiome for developing the disease. Thus, it is hypothesized that gut microbiome manipulation may arise as a way of treating psoriasis. However, few trials assessed the use of probiotics in psoriasis, although promising results were detected in small studies. Our objective was to assess the efficacy of adjuvant probiotics (Lactobacillus rhamnosus) in treating plaque psoriasis patients. This was a randomized, parallel, placebo-controlled, double-blind trial with two arms: experimental (n = 50) and control (n = 53). Inclusion of subjects and data gathering lasted from November 2020 to August 2021. Subjects were consecutive plaque psoriasis patients under regular follow-up in the Dermatology unit of a university-affiliated, tertiary-referral hospital in São Paulo (Brazil). Eligibility criteria included being over 18 years old, having plaque psoriasis and not having other skin diseases, neoplasms nor systemic inflammatory diseases. Subjects received standard-of-care plus probiotics (Lactobacillus rhamnosus formula). Controls received standard-of-care plus placebo. Primary outcome was skin lesion improvement as assessed by psoriasis area of severity index (PASI) at six months. Secondary outcome was quality-of-life as assessed by dermatology life quality index (DLQI) at six months. Regarding within-group analyses, changes in both PASI and DLQI were non-significant for the experimental group (mean PASI decreased by 1.58, p = 0.105, and mean DLQI increased by 0.05, p = 0.873) and significant for controls (mean PASI decreased by 1.90, p = 0.019, and mean DLQI decreased by 3.33, p = 0.031). Between-group analyses returned non-significant results (p = 0.620). Our findings do not support the hypothesis that gut microbiome modulation via ingestion of Lactobacillus rhamnosus produces clinical improvement in psoriasis patients. Further research is encouraged.

Trial registration: Retrospectively registered at the Brazilian Clinical Trials Registry (RBR-8js7t83) on 08/02/2022.

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Availability of data and materials

All data generated or analyzed during this study are included in this article and its supplementary files.

Abbreviations

BMI:

Body mass index

CI:

Confidence interval

CNPq:

Conselho Nacional de Desenvolvimento Científico e Tecnológico

CONSORT:

Consolidated standards of reporting trials

DLQI:

Dermatology life quality index

ITT:

Intention-to-treat

NSDUH-M:

National survey on drug use and health-modified

OR:

Odds ratio

PASI:

Psoriasis area of severity index

PP:

Per-protocol

SD:

Standard deviation

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Acknowledgements

The research team is thankful for the logistical support provided by the Dermatology residents of the Central Hospital of the Irmandade da Santa Casa de Misericórdia de São Paulo, namely: Juliana Milhomem Tamanini, MD; Lilian Lemos Costa, MD; Mariana Duarte Lopes, MD; Milton Ferreira Neves Neto, MD; Natália Costa de Almeida, MD; Paula Brigagão Alcântara Martins Amorim Lopes, MD; and Sandy Daniele Germano Munhoz, MD. Also, we are thankful for the support provided by Caio Cesar dos Santos Kasai, from Pontifícia Universidade Católica do Paraná (Londrina), with the statistical analyses. There are no conflicts of interest to disclose.

Funding

The first author (Enrico Stefano Suriano) received two research scholarships from the Institutional Scientific Initiation Scholarship Program of the Santa Casa de São Paulo Medical School (2019/2020 and 2021/2022), under the registration number 126840/2021-0. Such funding is offered by the National Council for Scientific and Technological Development (CNPq). However, these scholarships are provided only to foster undergraduates’ participation in research projects and were not used to fund the study. Probiotic and placebo vials were donated by Probac do Brasil Produtos Bacteriologicos LTDA.

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Authors and Affiliations

  1. Santa Casa de São Paulo Medical School, R. Dr. Cesário Mota Júnior, 61 Vila Buarque, São Paulo, SP, 01221020, Brazil

    Enrico Stefano Suriano, Marília Diogo Moço Souza, Clarice Marie Kobata, Felipe Henrique Yazawa Santos & Marcelo Jenné Mimica

  2. Rua Corrientes, 135, Apartment 42W, Lapa, São Paulo, SP, 05076010, Brazil

    Enrico Stefano Suriano

Authors
  1. Enrico Stefano Suriano
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  2. Marília Diogo Moço Souza
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  3. Clarice Marie Kobata
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  4. Felipe Henrique Yazawa Santos
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Contributions

All authors contributed to the study’s conception and design. Data gathering, data analysis and first draft writing were performed by ESS and MDMS. All authors commented on previous versions of the manuscript and approved its final version.

Corresponding author

Correspondence to Enrico Stefano Suriano.

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Conflict of interest

All authors state that there are no conflicts of interest to disclose.

Ethics approval

The research protocol was approved by our Institutional Review Board on 09/24/2019 (under the registration number 16435719.3.0000.5479).

Informed consent

In accordance with the Declaration of Helsinki, all participants provided written informed consent before inclusion, for both participation and data publication. Patient consent is stored on file and readily available upon request.

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Supplementary Information

Below is the link to the electronic supplementary material.

403_2023_2553_MOESM1_ESM.docx

Supplementary file1 Online Resource 1: between-group differences in PASI 50, PASI 75 and PASI 90 (PASI = Psoriasis Area of Severity Index). (DOCX 13 KB)

403_2023_2553_MOESM2_ESM.docx

Supplementary file2 Online Resource 2: logistic regressions’ results on the relationship between PASI 50, PASI 75 and PASI 90 and other relevant variables (CI = Confidence Interval; DLQI = Dermatology Life Quality Index; OR = Odds Ratio; PASI = Psoriasis Area of Severity Index) (DOCX 16 KB)

403_2023_2553_MOESM3_ESM.docx

Supplementary file3 Online Resource 3: spreadsheet with all raw data that was collected and analyzed in this article. (DOCX 13 KB)

Supplementary file4 (XLSX 33 KB)

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Suriano, E.S., Souza, M.D.M., Kobata, C.M. et al. Efficacy of an adjuvant Lactobacillus rhamnosus formula in improving skin lesions as assessed by PASI in patients with plaque psoriasis from a university-affiliated, tertiary-referral hospital in São Paulo (Brazil): a parallel, double-blind, randomized clinical trial. Arch Dermatol Res 315, 1621–1629 (2023). https://doi.org/10.1007/s00403-023-02553-1

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