Efficacy and safety of fecal microbiota transplantation for the induction of remission in active ulcerative colitis: a systematic review and meta-analysis of randomized controlled trials

Wei, Zhengjie; Dong, Hui; Ren, Yun; Jiang, Bo

doi:10.21037/atm-22-3236

Cited by 10 publications

(11 citation statements)

References 28 publications

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“…Importantly, AEs and SAEs were reported in only two of their four studies, and none of their SAEs were attributable to death. In another meta-analysis of FMT safety in a UC population of all ages from 2022, SAEs occurred at a pooled rate of 10% [ 45 ]. Unfortunately, it is unclear if there was any mortality in this data set.…”

Section: Discussionmentioning

confidence: 99%

Safety and Efficacy of Fecal Microbiota Transplantation in Treatment of Inflammatory Bowel Disease in the Pediatric Population: A Systematic Review and Meta-Analysis

et al. 2023

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Background and Aims: Fecal microbiota transplantation (FMT) has been increasingly studied in the inflammatory bowel disease (IBD) population. However, most studies have focused on the adult population, and the safety and efficacy of FMT in a pediatric population is less well understood. This systematic review and meta-analysis investigates the safety and efficacy of FMT in a pediatric IBD population. Methods: A comprehensive literature search of publications published prior to 30 June 2022 was undertaken. Safety data, IBD-related outcomes, and microbiome analysis were obtained from these studies when accessible. Individual estimates of each study were pooled, and sensitivity analysis was conducted. Results: Eleven studies satisfied our eligibility criteria. The calculated pooled rate of adverse events was 29% (95% confidence interval [CI]: 15.0%, 44.0%; p < 0.001; I2 = 89.0%, Q = 94.53), and the calculated pooled rate of serious adverse events was 10% (95% confidence interval [CI]: 6.0%, 14.0%; p = 0.28; I2 = 18.0%, Q = 9.79). One month after FMT, clinical response was achieved in 20/34 (58.8%) pediatric IBD patients, clinical remission was achieved in 22/34 (64.7%), and both clinical response and remission were achieved in 15/34 (44.1%) pediatric IBD patients. Conclusions: FMT can be a safe and effective treatment in the pediatric IBD population and may demonstrate improved safety and efficacy in the pediatric population compared to the adult population. However, our results are limited by a lack of established protocol as well as long-term follow-up for FMT in a pediatric IBD population.

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Section: Discussionmentioning

confidence: 99%

Safety and Efficacy of Fecal Microbiota Transplantation in Treatment of Inflammatory Bowel Disease in the Pediatric Population: A Systematic Review and Meta-Analysis

et al. 2023

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“…This is because the studies had very few participants and were not conducted using reliable methods. [9,10,39] In addition to the inherent limitations of reticulated meta-trials, our analysis also has limitations. Thorough comparative analyses of all drugs were limited to trials of induction therapy, making it difficult to assess their effectiveness due to differences in the design of maintenance therapy trials.…”

Section: Discussionmentioning

confidence: 99%

“…Recently, studies have shown that microbiome therapies, including probiotics, synbiotics, and fecal microbiota transplant (FMT), are also a potential Medicine therapy for inflammatory bowel disease and irritable bowel syndrome. [9,10] The majority of research has directly contrasted the effectiveness of placebos and biological agents with that of small molecule medications. [11][12][13] The effects of various biologics or between biologics and small molecule medications have only been directly compared in a limited number of trials.…”

Section: Introductionmentioning

confidence: 99%

Comparative of the effectiveness and safety of biological agents, small molecule drugs, and microbiome therapies in ulcerative colitis: Systematic review and network meta-analysis

Gao,

Nie,

Chen

et al. 2023

Medicine

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Background: Biological agents are commonly used for the first-line treatment of ulcerative colitis (UC). However, small-molecule drugs and microbiome therapies are now being used as new treatments for ulcerative colitis. We aimed to compare the relative efficacy and safety of biologics, small-molecule drugs, and microbiome therapies for the treatment of patients with moderate-to-severe ulcerative colitis. Methods: We searched the Cochrane, Embase, and PubMed databases from their inception to December 2022. RCTs that recruited patients with moderate-to-severe ulcerative colitis treated with biological agents, small-molecule drugs, and microbiome therapies. Efficacy outcomes were induction of clinical remission and mucosal healing; safety outcomes were adverse events and serious adverse events. A network meta-analysis with multivariate consistency model random-effect meta-regression was done, with rankings based on surface under the cumulative ranking curve (SUCRA) values. Higher SUCRA scores correlate with better efficacy, whereas lower SUCRA scores correlate with better safety. Results: A total of 31 RCTs comprising 7933 UC patients were included in our studies. A risk of bias assessment showed a low risk of bias for most of the included studies. Upadacitinib ranked highest for induction of clinical remission (SUCRA, 0.83) and mucosal healing (SUCRA, 0.44). Moreover, no treatments were found to increase the occurrence of adverse events compared with placebos. Ustekinumab ranked lowest for adverse events (SUCRA 0.26) and probiotic ranked lowest for serious adverse events (0·21), whereas tofacitinib ranked highest for adverse events (0·43) and upadacitinib ranked highest for serious adverse events (0·43). Conclusion: In this systematic review and network meta-analysis, we found upadacitinib to be ranked highest for the induction of clinical remission and mucosal healing, but the worst performing agent in terms of adverse events in UC patients. Probiotics were the best-performing agent for safety outcomes. More trials of direct comparisons are needed to inform clinical decision-making with greater confidence.

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“…Studies using higher doses of donor feces ( > 275 g) were associated with higher response rates (52% vs. 30%) than those using lower doses. Similarly, subgroup analysis by Wei et al [ 83 ] found benefit of FMT in induction of remission of UC only when the cumulative dose was higher than 300 g (risk ratio [RR], 1.85; 95% confidence interval [CI], 1.22–2.83) but not in lower doses. To achieve these doses, several sessions may be required, and there may be differences in optimum doses for induction versus maintenance of remission in IBD.…”

Section: Procedure-related Factors and Outcome Determinants In Fmtmentioning

confidence: 96%

The practice of fecal microbiota transplantation in inflammatory bowel disease

Arora,

Kedia,

Ahuja

2024

Intest Res

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Current evidence posits a central role for gut microbiota and the metabolome in the pathogenesis and progression of inflammatory bowel disease (IBD). Fecal microbiota transplantation (FMT) has been established as a means to manipulate this microbiome safely and sustainably. Several aspects of the technical improvement including pretreatment with antibiotics, use of frozen stool samples as well as short donor-to-recipient time are proposed to improve its response rates. Its efficacy in ulcerative colitis has been proven in clinical trials while data is emerging for Crohn’s disease. This review describes briefly the biology behind FMT, the available evidence for its use in IBD, and the host, recipient and procedural factors which determine the clinical outcomes.

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Efficacy and safety of fecal microbiota transplantation for the induction of remission in active ulcerative colitis: a systematic review and meta-analysis of randomized controlled trials

Cited by 10 publications

References 28 publications

Safety and Efficacy of Fecal Microbiota Transplantation in Treatment of Inflammatory Bowel Disease in the Pediatric Population: A Systematic Review and Meta-Analysis

Safety and Efficacy of Fecal Microbiota Transplantation in Treatment of Inflammatory Bowel Disease in the Pediatric Population: A Systematic Review and Meta-Analysis

Comparative of the effectiveness and safety of biological agents, small molecule drugs, and microbiome therapies in ulcerative colitis: Systematic review and network meta-analysis

The practice of fecal microbiota transplantation in inflammatory bowel disease

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