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Meta-Analysis
. 2024 Nov 11;24(1):402.
doi: 10.1186/s12876-024-03487-2.

Safety comparison of single-donor and pooled fecal microbiota transfer product preparation in ulcerative colitis: systematic review and meta-analysis

Bastien Laperrousaz  1 , Benoît Levast  2 , Mathieu Fontaine  2 , Stéphane Nancey  3 , Pierre Dechelotte  4 , Joël Doré  5 , Philippe Lehert  6   7
Affiliations
Meta-Analysis

Safety comparison of single-donor and pooled fecal microbiota transfer product preparation in ulcerative colitis: systematic review and meta-analysis

Bastien Laperrousaz et al. BMC Gastroenterol. .

Abstract

Background: Multiple studies have evaluated fecal microbiota transfer (FMT) in patients with ulcerative colitis (UC) using single-donor (SDN) and multidonor (MDN) products. Systematic review and meta-analysis were performed to compare the safety of SDN and MDN products.

Methods: Systematic searches were performed in Web of Science, Scopus, PubMed, and Orbit Intelligence to identify studies that compared FMT products manufactured using SDN or MDN strategies against control treatment in patients with UC. Fifteen controlled studies were selected for meta-analysis (11 randomized controlled trials and 4 controlled cohort trials). Safety of each treatment type was assessed using the counts of adverse events and serious adverse events using fixed- and random-effects models. Significance of the indirect difference between FMT preparations was assessed using a network approach. Benefit-risk ratios were calculated by multiplicative utility model, incorporating geometric mean of risk ratios (RRs) of efficacy and safety.

Results: Safety data was collected for a total of 587 patients (193 exposed to SDN products, 114 exposed to MDN products and 280 exposed to control treatment). The 12 studies showed similar overall safety event counts for MDN and SDN versus placebo (RRs: 0.90 and 1.09, respectively [P = 0.206 and P = 0.420, respectively]). Results indicated similar risk of safety events for MDN compared to SDN (RR: 0.83, P = 0.159). Positive benefit-risk ratios were demonstrated for MDN and SDN versus placebo (RRs: 1.70 and 1.16, respectively [P = 0.003 and P = 0.173, respectively]). MDN had a greater benefit-risk ratio compared to SDN (RR: 1.46, P = 0.072).

Conclusion: Similar safety profiles were observed for MDN and SDN strategies. Alongside previously described superior efficacy, treatment with MDN has greater benefit-risk ratio than SDN in patients with UC. Further development of MDN FMT treatment for UC should be considered.

Keywords: Benefit-risk; Fecal microbiota transfer; Meta-analysis; Pooling; Safety; Ulcerative colitis.

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Conflict of interest statement

Declarations Ethics approval and consent to participate Not applicable. Consent for publication Not applicable. Competing interests The study was funded by MaaT Pharma, France; http://www.maatpharma.com. An unconditional grant was provided to the authors, and MaaT Pharma was not involved in writing the protocol, statistical plan, or discussion of results.

Figures

Fig. 1
Fig. 1
PRISMA flow diagram showing the study selection process. n, number of records; PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses. From Page et al. [6]
Fig. 2
Fig. 2
Forest plot of safety analysis for all safety events. CI, confidence interval; MDN, multidonor; RR, risk ratio; SDN, single donor. Comparison of SDN and MDN was performed by using placebo as the null reference. RR SDN/placebo and MDN/placebo
Fig. 3
Fig. 3
Forest plot of benefit-risk analysis. CI, confidence interval; MDN, multidonor; RR, risk ratio; SDN, single donor. Comparison of SDN and MDN was performed by using placebo as the null reference. RR SDN/placebo and MDN/placebo
See this image and copyright information in PMC

References

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