PMID- 36003050 OWN - NLM STAT- MEDLINE DCOM- 20220826 LR - 20221207 IS - 1399-3038 (Electronic) IS - 0905-6157 (Print) IS - 0905-6157 (Linking) VI - 33 IP - 8 DP - 2022 Aug TI - Therapeutic effects elicited by the probiotic Lacticaseibacillus rhamnosus GG in children with atopic dermatitis. The results of the ProPAD trial. PG - e13836 LID - 10.1111/pai.13836 [doi] LID - e13836 AB - 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 10(10) 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. CI - (c) 2022 The Authors. Pediatric Allergy and Immunology published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd. FAU - Carucci, Laura AU - Carucci L AUID- ORCID: 0000-0001-7490-3999 AD - Department of Translational Medical Science, University of Naples Federico II, Naples, Italy. AD - ImmunoNutritionLab at the CEINGE Advanced Biotechnologies Research Center, University of Naples Federico II, Naples, Italy. FAU - Nocerino, Rita AU - Nocerino R AUID- ORCID: 0000-0003-4681-546X AD - Department of Translational Medical Science, University of Naples Federico II, Naples, Italy. AD - ImmunoNutritionLab at the CEINGE Advanced Biotechnologies Research Center, University of Naples Federico II, Naples, Italy. FAU - Paparo, Lorella AU - Paparo L AUID- ORCID: 0000-0002-5562-1408 AD - Department of Translational Medical Science, University of Naples Federico II, Naples, Italy. AD - ImmunoNutritionLab at the CEINGE Advanced Biotechnologies Research Center, University of Naples Federico II, Naples, Italy. FAU - De Filippis, Francesca AU - De Filippis F AD - Department of Agricultural Sciences, University of Naples Federico II, Naples, Italy. AD - Task Force on Microbiome Studies University of Naples Federico II, Naples, Italy. FAU - Coppola, Serena AU - Coppola S AD - Department of Translational Medical Science, University of Naples Federico II, Naples, Italy. AD - ImmunoNutritionLab at the CEINGE Advanced Biotechnologies Research Center, University of Naples Federico II, Naples, Italy. FAU - Giglio, Veronica AU - Giglio V AD - Department of Translational Medical Science, University of Naples Federico II, Naples, Italy. AD - ImmunoNutritionLab at the CEINGE Advanced Biotechnologies Research Center, University of Naples Federico II, Naples, Italy. FAU - Cozzolino, Tommaso AU - Cozzolino T AD - Department of Translational Medical Science, University of Naples Federico II, Naples, Italy. AD - ImmunoNutritionLab at the CEINGE Advanced Biotechnologies Research Center, University of Naples Federico II, Naples, Italy. FAU - Valentino, Vincenzo AU - Valentino V AD - Department of Agricultural Sciences, University of Naples Federico II, Naples, Italy. FAU - Sequino, Giuseppina AU - Sequino G AD - Department of Agricultural Sciences, University of Naples Federico II, Naples, Italy. FAU - Bedogni, Giorgio AU - Bedogni G AUID- ORCID: 0000-0002-1495-9306 AD - Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy. AD - Internal Medicine, S. Maria delle Croci Hospital, AUSL Romagna, Ravenna, Italy. FAU - Russo, Roberto AU - Russo R AD - Department of Pharmacy, University of Naples Federico II, Naples, Italy. FAU - Ercolini, Danilo AU - Ercolini D AD - Department of Agricultural Sciences, University of Naples Federico II, Naples, Italy. AD - Task Force on Microbiome Studies University of Naples Federico II, Naples, Italy. FAU - Berni Canani, Roberto AU - Berni Canani R AUID- ORCID: 0000-0002-5169-9574 AD - Department of Translational Medical Science, University of Naples Federico II, Naples, Italy. AD - ImmunoNutritionLab at the CEINGE Advanced Biotechnologies Research Center, University of Naples Federico II, Naples, Italy. AD - Task Force on Microbiome Studies University of Naples Federico II, Naples, Italy. AD - European Laboratory for the Investigation of Food-Induced Diseases, University of Naples Federico II, Naples, Italy. LA - eng SI - ClinicalTrials.gov/NCT03863418 PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - England TA - Pediatr Allergy Immunol JT - Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology JID - 9106718 SB - IM MH - Child MH - *Dermatitis, Atopic/therapy MH - Double-Blind Method MH - Humans MH - Infant MH - *Lacticaseibacillus rhamnosus MH - *Probiotics/therapeutic use MH - Quality of Life MH - Severity of Illness Index MH - Treatment Outcome PMC - PMC9542056 OTO - NOTNLM OT - butyrate OT - gut microbiome OT - infant dermatitis quality of life questionnaire (IDQOL) OT - scoring atopic dermatitis (SCORAD) index OT - skin microbiome COIS- The authors have no conflict of interest to declare. EDAT- 2022/08/26 06:00 MHDA- 2022/08/27 06:00 PMCR- 2022/10/07 CRDT- 2022/08/25 02:02 PHST- 2022/07/08 00:00 [revised] PHST- 2022/04/16 00:00 [received] PHST- 2022/07/11 00:00 [accepted] PHST- 2022/08/25 02:02 [entrez] PHST- 2022/08/26 06:00 [pubmed] PHST- 2022/08/27 06:00 [medline] PHST- 2022/10/07 00:00 [pmc-release] AID - PAI13836 [pii] AID - 10.1111/pai.13836 [doi] PST - ppublish SO - Pediatr Allergy Immunol. 2022 Aug;33(8):e13836. doi: 10.1111/pai.13836.