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BACKGROUND: Ulcerative colitis (UC) is a chronic relapsing disease characterised by diffuse mucosal inflammation limited to the colon. Current maintenance treatments have multiple adverse events and an effective treatment with minimal adverse events is desired. Several studies have demonstrated the importance of intestinal flora in the pathogenesis of ulcerative colitis. It has been suggested that modifying the bacteria flora with probiotics may attenuate the inflammatory process and prevent relapses in UC. METHODS: Data extraction and risk of bias assessment of included studies were independently performed by 2 authors, data was analysed using Review Manager 5.3, dichotomous and continuous outcomes were expressed as risk ratios (RR) and mean differences (MD) with 95% confidence intervals (CI). The certainty of evidence was assessed using GRADE methodology. RESULTS: Eleven studies (1,204 randomised participants) met the inclusion criteria. The studies compared probiotics to placebo, probiotics to 5-ASA and a combination of probiotics and 5-ASA to 5-ASA. The risk of bias was high in all except 3 studies due to selective reporting, incomplete outcome data and lack of blinding, this results in low to very low rating of the quality of the evidence. There is no clear difference in relapse when probiotics are compared with placebo (RR, 0.86; 95% CI, 0.71–1.04; 341 participants, 5 studies; low quality of evidence). There is no clear difference in maintenance of remission when probiotics are compared with 5-ASA (RR, 1.05; 95% CI, 0.89–1.24; 122 participants; 2 studies; low quality of evidence). There is no clear difference in maintenance of remission when probiotics coupled with—ASA are compared to 5-ASA alone (RR, 1.49; 95% CI, 0.86–2.57; 92 participants; 2 studies; very low quality evidence). CONCLUSION(S): Given the limited data and high risk of bias in the included studies, there is insufficient evidence to make conclusion about the efficacy of probiotics for maintenance of remission in UC. This is based on low to very low quality of evidence. This review highlights the need for further well-designed randomised controlled trials (RCT) to investigate the above objective. Future research should focus on comparing probiotics with 5-ASA as this will reflect clinical practise, patients are unlikely to not be on any treatment to maintain remission. Additionally, length of follow up of most studies in this review is much less than other published reviews, studies looking at 12 months or less are simply too limited in their usefulness to clinical practise. Overall this is the second review for the above objective and it is surprising to see that similar issues exist that did in the first review such as small participants numbers. The issues highlighted in this review should be taken into account for any authors that wish to produce well-designed RTCS looking at the usefulness of probiotics for patients with UC. Some staff received funding from NIHR Cochrane programme.

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BACKGROUND: Ulcerative colitis (UC) is a disease that causes inflammation of the colon and has an incidence of approximately 10–20 per 100,000 per year. At present, the therapies that exist to treat UC are unfortunately coupled with unfavourable side effects which has resulted in a demand for new alternatives. Probiotics are live microbial feed supplements that may benefit the host by improving intestinal microbial balance, enhancing the gut barrier function and improving local immune response. METHODS: Data extraction and risk of bias assessments of included studies were conducted independently by 2 authors. Data was analysed using review manger 5.3. Dichotomous and continuous outcomes were expressed at risk ratio (RR) and mean differences (MDs) with 95% confidence intervals (CIs). The certainty of the evidence was assessed using GRADE methodology. RESULTS: Twelve studies (755 randomised participants) met the inclusion criteria, 10 studies looked adults while the remaining 2 looked at paediatric patients. The studies compared probiotics vs placebo, probiotics vs 5-ASA and combination of probiotics plus 5-ASA vs 5-ASA alone. The studies ranged from 2 weeks to 52 weeks. The main results included that probiotics may improve the induction of remission when compared with placebo (RR, 1.73; 95% CI, 1.17–2.56; 560 participants; 8 studies; low quality of evidence) and they probably also improve disease severity when compared with placebo (RR, 1.54; CI, 1.11–2.13; 164 participants; 2 studies; moderate quality evidence). When probiotics are compared to 5-ASA it is uncertain whether they offer better chances of remission (RR, 0.92; 95% CI, 0.73–1.16; 116 participants; 1 study; very low-quality evidence). However, when probiotics are coupled with 5-ASA they may slightly improve the induction of remission compared to 5-ASA alone (RR, 1.22; CI, 1.01–1.47; 84 participants; 1 study; low quality evidence). For adverse events, probiotics did not lead to any serious adverse events in any of the 7 studies which reported on it, however the quality of the evidence was very low (RR, 0.09; CI, 0.01–1.66; 526 participants; 7 studies). CONCLUSION(S): There is low quality evidence which suggests that probiotics may be efficacious in inducing remission when compared with placebo. Whilst it is uncertain whether probiotics are more effective than 5-ASA, there is limited evidence that they may slightly improve the induction of remission when used in combination with 5-ASA. There is insufficient evidence to assess whether probiotics are effective in patients with severe and more extensive disease, or if specific preparations are superior to others. Further, targeted and appropriate powering of studies and the use of standardised patients' groups and outcome measures in line with the wider field are needed. In addition, the conception of trials must be considered, for example comparing probiotic to placebo is not representative of current clinical practise where patients who have active disease will be treated with some sort of therapy to aid remission. Grants/Declarations: Some staff were funded by the NIHR Cochrane Programme.