Effect of probiotics on gastrointestinal symptoms and immune parameters in systemic sclerosis: a randomized placebo-controlled trial

Abstract

Objectives 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. Methods 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. Results 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. Conclusion Probiotics did not improve GI symptoms in SSc patients. The reduction in Th17 cell levels suggests an immunomodulatory effect of probiotics on SSc. Trial registration ClinicalTrials.gov (http://clinicaltrials.gov), NCT 02302352.

Gastrointestinal involvement in systemic sclerosis: Effects on morbidity and mortality and new therapeutic approaches

“…An RCT including 73 patients, receiving either probiotics (n = 37) or placebo (n = 36), evaluated the efficacy of probiotics on GI symptoms and immune responses in SSc patients. 36 After 8 weeks, no difference in the UCLA GIT 2.0 score between the two groups was observed, but the probiotic group showed a significant decrease in the proportion of Th17 cells compared with placebo. No severe side-effects were observed in this study.…”

“…No severe side-effects were observed in this study. 36 Of note, there have been some concerns regarding the safety of probiotic use in immunocompromised patients developing life-threatening pneumonia, endocarditis, and sepsis due to some probiotic strains becoming opportunistic pathogens. 37 To our knowledge, there are no reports regarding safety issues associated with probiotic use in SSc patients to date.…”

The efficacy and safety of fecal microbiota transplantation in the treatment of systemic sclerosis

“…[ 29 ] Recently, the pathogenesis of SSc has been reported to be related to the dysbiosis of gut microbiota. [ 30 , 31 ] Though there are several issues to be understood, FMT has been as an innovative approach to SSc. [ 32 ] However, as far as we know,no literature review systematically assesses the efficacy and safety of FMT in the treatment of SSc.…”

Benefits of Probiotics in Rheumatic Diseases

“…As far as SSc is concerned, some RCTs have been carried out only in patients with gastrointestinal involvement. One of these has shown that an 8-week probiotics supplementation did not have any effect in reducing gastrointestinal symptoms but lead to a decrease in Th17 cell levels indicating an immunomodulatory capacity of the probiotic strains used ( Table 1) (17). Another trial confirmed the inefficacy of probiotics in systemic sclerosis associated gastrointestinal disease but SSc clinical outcomes were not addressed in that study (30).…”