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

40 patients with systemic sclerosis and gastrointestinal symptoms were randomised to 60 days of high-dose multi-strain probiotics (1,800 billion units/day, n = 19) or placebo (n = 21), after which both groups took probiotics for a further 60 days. At day 60, the primary endpoint, there was no difference in total gastrointestinal symptom score (placebo 0.14 versus probiotics 0.13, p = 0.85) or any subdomain. At day 120 the total score still did not differ significantly (p = 0.14), but reflux improved significantly in the continuous-probiotic group (-0.22 versus +0.05, p = 0.004), and those on probiotics showed increasing stool microbiota diversity. Adverse events were mild and similar between groups.