Rheumatology Division, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, Brazil.
Rheumatology (Oxford). 2019 Nov 1;58(11):1985-1990. doi: 10.1093/rheumatology/kez160.
Changes in the intestinal microbiota have been associated with the pathogenesis of SSc. Probiotics act by modulating the microbiome and the immune response. This study aimed to evaluate the efficacy of probiotics on gastrointestinal (GI) symptoms and immune responses in SSc patients.
Patients with SSc with a moderate-severe total score on the University of California Los Angeles Scleroderma Clinical Trials Consortium Gastrointestinal Tract 2.0 (UCLA GIT 2.0) instrument were randomly assigned to receive a daily dose of probiotics (Lactobacillus paracasei, Lactobacillus rhamnosus, Lactobacillus acidophillus and Bifidobacterium lactis, 109 colony-forming units per capsule) or placebo for 8 weeks. The primary endpoint was improvement in the UCLA GIT 2.0 total score after 8 weeks. Secondary outcomes included changes in Th1, Th2, Th17 and regulatory T cell circulating levels and in the HAQ Disability Index (HAQ-DI) score. Parameters were assessed at baseline and after 4 and 8 weeks of treatment.
A total of 73 patients were randomized to receive probiotics (n = 37) or placebo (n = 36). After 8 weeks, there was no difference in the UCLA GIT 2.0 score between the two groups. At week 8, the probiotic group showed a significant decrease in the proportion of Th17 cells compared with placebo (P = 0.003). There was no difference in the proportion of Th1, Th2 and regulatory T cells or in the HAQ-DI score between the groups.
Probiotics did not improve GI symptoms in SSc patients. The reduction in Th17 cell levels suggests an immunomodulatory effect of probiotics on SSc.
ClinicalTrials.gov (http://clinicaltrials.gov), NCT02302352.
肠道微生物群的变化与 SSc 的发病机制有关。益生菌通过调节微生物组和免疫反应起作用。本研究旨在评估益生菌对 SSc 患者胃肠道（GI）症状和免疫反应的疗效。
UCLA Scleroderma Clinical Trials Consortium GI 2.0（UCLA GIT 2.0）仪器中度至重度总分的 SSc 患者被随机分配接受每日剂量的益生菌（副干酪乳杆菌、鼠李糖乳杆菌、嗜酸乳杆菌和双歧杆菌，每胶囊 109 个菌落形成单位）或安慰剂 8 周。主要终点是 8 周后 UCLA GIT 2.0 总评分的改善。次要结局包括 Th1、Th2、Th17 和调节性 T 细胞循环水平以及 HAQ 残疾指数（HAQ-DI）评分的变化。参数在基线和治疗 4 周和 8 周后进行评估。
共有 73 名患者被随机分配接受益生菌（n = 37）或安慰剂（n = 36）。8 周后，两组之间 UCLA GIT 2.0 评分无差异。第 8 周时，与安慰剂组相比，益生菌组 Th17 细胞的比例显著下降（P = 0.003）。两组之间 Th1、Th2 和调节性 T 细胞的比例或 HAQ-DI 评分没有差异。
益生菌不能改善 SSc 患者的 GI 症状。Th17 细胞水平的降低表明益生菌对 SSc 具有免疫调节作用。
ClinicalTrials.gov（http://clinicaltrials.gov），NCT02302352。
