Therapeutic effects elicited by the probiotic Lacticaseibacillus rhamnosus GG in children with atopic dermatitis. The results of the ProPAD trial

Laura Carucci; Rita Nocerino; Lorella Paparo; Francesca De Filippis; Serena Coppola; Veronica Giglio; Tommaso Cozzolino; Vincenzo Valentino; Giuseppina Sequino; Giorgio Bedogni; Roberto Russo; Danilo Ercolini; Roberto Berni Canani

doi:10.1111/pai.13836

Therapeutic effects elicited by the probiotic Lacticaseibacillus rhamnosus GG in children with atopic dermatitis. The results of the ProPAD trial

Pediatr Allergy Immunol. 2022 Aug;33(8):e13836. doi: 10.1111/pai.13836.

Authors

Laura Carucci^{1

2}, Rita Nocerino^{1

2}, Lorella Paparo^{1

2}, Francesca De Filippis^{3

4}, Serena Coppola^{1

2}, Veronica Giglio^{1

2}, Tommaso Cozzolino^{1

2}, Vincenzo Valentino³, Giuseppina Sequino³, Giorgio Bedogni^{5

6}, Roberto Russo⁷, Danilo Ercolini^{3

4}, Roberto Berni Canani^{1

2

4

8}

Affiliations

¹ Department of Translational Medical Science, University of Naples Federico II, Naples, Italy.
² ImmunoNutritionLab at the CEINGE Advanced Biotechnologies Research Center, University of Naples Federico II, Naples, Italy.
³ Department of Agricultural Sciences, University of Naples Federico II, Naples, Italy.
⁴ Task Force on Microbiome Studies University of Naples Federico II, Naples, Italy.
⁵ Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy.
⁶ Internal Medicine, S. Maria delle Croci Hospital, AUSL Romagna, Ravenna, Italy.
⁷ Department of Pharmacy, University of Naples Federico II, Naples, Italy.
⁸ European Laboratory for the Investigation of Food-Induced Diseases, University of Naples Federico II, Naples, Italy.

Abstract

Background: Atopic dermatitis (AD) is a chronic inflammatory skin disease affecting up to 20% of the pediatric population associated with alteration of skin and gut microbiome. Probiotics have been proposed for AD treatment. The ProPAD study aimed to investigate the therapeutic effects of the probiotic Lacticaseibacillus rhamnosus GG (LGG) in children with AD.

Methods: In total, 100 AD patients aged 6-36 months were enrolled in a randomized, double-blind, controlled trial to receive placebo (Group A) or LGG (1 x 10¹⁰ CFU/daily) (Group B) for 12 weeks. The primary outcome was the evaluation of the efficacy of LGG supplementation on AD severity comparing the Scoring Atopic Dermatitis (SCORAD) index at baseline (T0) and at 12-week (T12). A reduction of ≥8.7 points on the SCORAD index was considered as minimum clinically important difference (MCID). The secondary outcomes were the SCORAD index evaluation at 4-week (T16) after the end of LGG treatment, number of days without rescue medications, changes in Infant Dermatitis Quality Of Life questionnaire (IDQOL), gut microbiome structure and function, and skin microbiome structure.

Results: The rate of subjects achieving MCID at T12 and at T16 was higher in Group B (p < .05), and remained higher at T16 (p < .05)The number of days without rescue medications was higher in Group B. IDQOL improved at T12 in the Group B (p < .05). A beneficial modulation of gut and skin microbiome was observed only in Group B patients.

Conclusions: The probiotic LGG could be useful as adjunctive therapy in pediatric AD. The beneficial effects on disease severity and quality of life paralleled with a beneficial modulation of gut and skin microbiome.

Trial registration: ClinicalTrials.gov NCT03863418.

Keywords: butyrate; gut microbiome; infant dermatitis quality of life questionnaire (IDQOL); scoring atopic dermatitis (SCORAD) index; skin microbiome.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Child
Dermatitis, Atopic* / therapy
Double-Blind Method
Humans
Infant
Lacticaseibacillus rhamnosus*
Probiotics* / therapeutic use
Quality of Life
Severity of Illness Index
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT03863418