Table 5.

Clinical trials assessing the safety and efficacy of probiotics in SSc.

Study	N	Probiotic	Design	Duration	Outcome
Frech et al. 2011 (66)	10	Align (Bifidobacterium infantis; 109 CFU per capsule) or Culturelle (Lactobacillus GG; 109 Colony-forming units (CFU) per capsule	Open-label	8 weeks	Improvement in total GIT 2.0 score and 3 individual domains (reflux, bloating, emotional)
Marighela et al. 2019 (67)	73	Lactobacillus paracasei, Lactobacillus rhamnosus, Lactobacillus acidophillus and Bifidobacterium lactis; 109 CFU per capsule	RCT	8 weeks	No improvement in GIT 2.0 scores; decrease in circulating Th17 cells in probiotic group; no difference in HAQ-DI, circulating Th1, Th2, or regulatory T cells between groups

GIT 2.0: UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract (UCLA SCTC GIT 2.0); HAQ-DI: Health Assessment Questionnaire-Disability Index.