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

Autor: Low AHL; Department of Rheumatology and Immunology, Singapore General Hospital, The Academia, Level 4, 20 College Road 169856, Singapore; Duke-National University of Singapore Medical School, 8 College Road 169857, Singapore. Electronic address: andrea.low.h.l@singhealth.com.sg., Teng GG; Division of Rheumatology, National University Hospital, National University Health System, 5 Lower Kent Ridge Road 119074, Singapore; Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, 1E Kent Ridge Road 119228, Singapore., Pettersson S; Lee Kong Chian School of Medicine, Nanyang Technological University, 59 Nanyang Drive, Experimental Medicine Building 636921, Singapore; Singapore Centre for Environmental Life Sciences Engineering Microbiome Centre, Nanyang Technological University, 60 Nanyang Drive 637551, Singapore., de Sessions PF; Genome Institute of Singapore, Agency for Science, Technology and Research, 60 Biopolis Street 138672, Singapore., Ho EXP; Genome Institute of Singapore, Agency for Science, Technology and Research, 60 Biopolis Street 138672, Singapore., Fan Q; Centre for Quantitative Medicine, Duke-NUS Medical School, 8 College Road 169857, Singapore., Chu CW; Genome Institute of Singapore, Agency for Science, Technology and Research, 60 Biopolis Street 138672, Singapore., Law AHN; Department of Rheumatology and Immunology, Singapore General Hospital, The Academia, Level 4, 20 College Road 169856, Singapore., Santosa A; Division of Rheumatology, National University Hospital, National University Health System, 5 Lower Kent Ridge Road 119074, Singapore; Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, 1E Kent Ridge Road 119228, Singapore., Lim AYN; Division of Rheumatology, National University Hospital, National University Health System, 5 Lower Kent Ridge Road 119074, Singapore; Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, 1E Kent Ridge Road 119228, Singapore., Wang YT; Gastroenterology and Hepatology, Singapore General Hospital, 20 College Road Singapore 169856., Haaland B; Centre for Quantitative Medicine, Duke-NUS Medical School, 8 College Road 169857, Singapore., Thumboo J; Department of Rheumatology and Immunology, Singapore General Hospital, The Academia, Level 4, 20 College Road 169856, Singapore; Duke-National University of Singapore Medical School, 8 College Road 169857, Singapore.
Jazyk: angličtina
Zdroj: Seminars in arthritis and rheumatism [Semin Arthritis Rheum] 2019 Dec; Vol. 49 (3), pp. 411-419. Date of Electronic Publication: 2019 May 23.
DOI: 10.1016/j.semarthrit.2019.05.006
Abstrakt: Objective: Assess whether treatment with probiotics improve gastrointestinal symptoms in patients with systemic sclerosis (SSc).
Methods: In this double-blind randomized placebo-controlled parallel-group phase II trial, SSc subjects with total score ≥ 0.1 on a validated SSc-specific gastrointestinal tract (GIT) questionnaire were randomized (1:1) to receive 60 days of high dose multi-strain probiotics (Vivomixx® 1800 billion units/day) or identical placebo, followed by an additional 60 days of probiotics in both groups. Between group differences in GIT score change were assessed after 60 days (primary outcome, time-point T1) and 120 days (secondary outcome, time-point, T2) by an intention-to-treat approach. Stool samples at three time-points were subjected to 16S next generation sequencing.
Results: Forty subjects were randomized to placebo-probiotics (n = 21) or probiotics-probiotics (n = 19). At T1, no significant improvement was observed between the two groups, reported as mean ± SE for total GIT score (placebo 0.14 ± 0.06 versus probiotics 0.13 ± 0.07; p = 0.85) or its subdomains. At T2, whilst there was no significant improvement in total GIT score (placebo-probiotics -0.05±0.06; probiotics-probiotics -0.18 ± 0.07; p = 0.14), there was significant improvement of GIT-reflux in the probiotic group (-0.22 ± 0.05 versus placebo-probiotics 0.05 ± 0.07; p = 0.004). Subjects on probiotics exhibited increasing stool microbiota alpha diversity compared to the placebo-probiotics group. Adverse events (AEs) were mild, with similar proportion of subjects with AEs and serious AEs in both groups.
Conclusion: Whilst there was no clear improvement in overall GI symptoms after 60 days, we observed significantly improved GI reflux after 120 days of probiotics. The trial confirmed safety of multi-strain probiotics in SSc patients.
Trial Registration: Clinicaltrials.gov; NCT01804959.
(Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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