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A double-blind randomized placebo-controlled trial of probiotics in systemic sclerosis associated gastrointestinal disease

Seminars in Arthritis and Rheumatism Jun 20, 2019

Low AHL, et al. - Through an investigator-initiated double-blind randomized placebo-controlled parallel-group phase II trial on 40 subjects, the observers assessed if treatment with probiotics could improve gastrointestinal symptoms in patients with systemic sclerosis (SSc). Increasing stool microbiota alpha diversity was observed in subjects on probiotics. Milder adverse events were noted. No statistically significant difference in the total gastrointestinal tract (GIT) score in comparison to the placebo group, whilst 60 days of probiotic treatment was observed, however, a significant improvement of the GIT-reflux subdomain but a non-significant improvement of the total GIT and GIT-distension subdomain was observed during 120 days of probiotics use. Furthermore, an independent association of certain microbial genera at baseline and their treatment with probiotics with improved GIT score at the secondary endpoint was reported.
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