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Side Effects Associated with Probiotic Use in Adult Patients with Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

1
Department of Medical, Surgical and Experimental Sciences, University of Sassari, 07100 Sassari, Italy
2
Baylor College of Medicine, Houston, TX 77030, USA
3
Gastroenterology and Hepatology Section, Department of Medicine, University of Perugia, 06123 Perugia, Italy
*
Author to whom correspondence should be addressed.
Nutrients 2019, 11(12), 2913; https://doi.org/10.3390/nu11122913
Received: 16 October 2019 / Revised: 18 November 2019 / Accepted: 27 November 2019 / Published: 2 December 2019
Probiotics demonstrated to be effective in the treatment of inflammatory bowel disease (IBD). However, the safety profile of probiotics is insufficiently explored. In the present systematic review and meta-analysis, we examined the occurrence of side effects related to probiotic/synbiotic use in randomized controlled trials (RCTs) of IBD patients as compared with placebo. Eligible RCTs in adult patients with IBD were identified by accessing the Medline database via PubMed, EMBASE, CENTRAL and the Cochrane central register of controlled trials up to December 2018. Occurrence of side effects was retrieved and recorded. Data were pooled and the relative risks (RRs) with their 95% confidence intervals (CIs) were calculated. The low-moderate study heterogeneity, assessed by the I2 statistic, allowed to use of a fixed-effects modelling for meta-analysis. Nine RCTs among 2337, including 826 patients (442 treated with probiotics/symbiotic and 384 with placebo) were analyzed. Eight were double-blind RCTs, and six enrolled ulcerative colitis (UC) patients. Although the risk for the overall side effects (RR 1.35, 95%CI 0.93–1.94; I2 = 25%) and for gastrointestinal symptoms (RR 1.78, 95%CI 0.99–3.20; I2 = 20%) was higher in IBD patients taking probiotics than in those exposed to placebo, statistical significance was achieved only for abdominal pain (RR 2.59, 95%CI 1.28–5.22; I2 = 40%). In conclusion, despite the small number of RCTs and the variety of probiotic used and schedule across studies, these findings highlight the level of research effort still required to identify the most appropriate use of probiotics in IBD. View Full-Text
Keywords: Crohn disease; ulcerative colitis; inflammatory bowel disease; probiotics; prebiotics; synbiotics Crohn disease; ulcerative colitis; inflammatory bowel disease; probiotics; prebiotics; synbiotics
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Dore, M.P.; Bibbò, S.; Fresi, G.; Bassotti, G.; Pes, G.M. Side Effects Associated with Probiotic Use in Adult Patients with Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Nutrients 2019, 11, 2913.

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