Side Effects Associated with Probiotic Use in Adult Patients with Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
Open accessAbstract
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.
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A meta-analysis of nine controlled trials in patients with inflammatory bowel disease showed higher adverse event risk with probiotics/synbiotics.
“A meta-analysis of nine controlled trials patients with inflammatory bowel disease showed higher AE risk with probiotics/synbiotics [111].”
From Current Concepts in Probiotic Safety and Efficacy (2026) · cites this paper as [111]
The authors of the IBD meta-analysis found no clear explanation for higher adverse event risk due to variations in study design and regimens.
“However, the authors found no clear explanation for this due to variations in study design and regimens.”
From Current Concepts in Probiotic Safety and Efficacy (2026) · cites this paper as [111]
Common probiotic side effects are bloating, gas, diarrhea, constipation, nausea, thirst, headaches and migraines, and skin reactions.
“Common probiotic side effects are bloating, gas, diarrhea, constipation, nausea [235,236], thirst, headaches and migraines, and skin reactions [234].”
From The Potential Impact of Probiotics on Human Health: An Update on Their Health-Promoting Properties (2024) · cites this paper as [236]
Mild gastrointestinal symptoms (gas and bloating) from probiotics usually improve within a few weeks.
“Mild gastrointestinal symptoms (gas and bloating), usually improve within a few weeks [236].”
From The Potential Impact of Probiotics on Human Health: An Update on Their Health-Promoting Properties (2024) · cites this paper as [236]
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- Authors
- Dore, M. P., Bibbò, S., Fresi, G., Bassotti, G., & Pes, G. M.
- Affiliations
- University of Sassari (IT)
- University of Perugia (IT)
- Corresponding author
- Pes, Giovanni Mario
- Venue
- Nutrients
- Publisher
- MDPI AG
- Published
- 2019-12-02
- Volume
- 11
- Issue
- 12
- Pages
- 2913
- ISSN
- 2072-6643 (ISSN-L)
- PMC
- PMC6950558
- OpenAlex
- W2990681752
- Cited by
- 83
- References
- 47
- Citations by year
- 2026: 8 · 2025: 28 · 2024: 19 · 2023: 11 · 2022: 8 · 2021: 5 · 2020: 4
- FWCI
- 0.38
- Type
- journal article
- Language
- en
- Open access
- gold
- dx.doi.org
- Licence
- Locations
- Nutrients (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- UnissResearch (Università degli Studi di Sassari) (submittedVersion)
- Topics
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Inflammatory Bowel Disease
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Keywords
- probiotics, synbiotics, inflammatory bowel disease, ulcerative colitis, adverse effects, gastrointestinal symptoms, abdominal pain, probiotic safety, placebo comparison
- MeSH terms
- Adult, Colitis, Ulcerative, Crohn Disease, Double-Blind Method, Female, Humans, Male, Inflammatory Bowel Diseases, Abdominal Pain, Randomized Controlled Trials as Topic, Probiotics, Synbiotics
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