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Gut Pathogens
Published in: Gut Pathogens 1/2022

Open Access 01-12-2022 | Respiratory Microbiota | Review

Adverse events of intestinal microbiota transplantation in randomized controlled trials: a systematic review and meta-analysis

Authors: Chong Chen, Liyu Chen, Dayong Sun, Cailan Li, Shiheng Xi, Shihua Ding, Rongrong Luo, Yan Geng, Yang Bai

Published in: Gut Pathogens | Issue 1/2022

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Abstract

Background

Intestinal microbiota transplantation (IMT) has been recognized as an effective treatment for recurrent Clostridium difficile infection (rCDI) and a novel treatment option for other diseases. However, the safety of IMT in patients has not been established.

Aims

This systematic review and meta-analysis was conducted to assess the safety of IMT.

Methods

We systematically reviewed all randomized controlled trials (RCTs) of IMT studies published up to 28 February 2021 using databases including PubMed, EMBASE and the Cochrane Library. Studies were excluded if they did not report adverse events (AEs). Two authors independently extracted the data. The relative risk (RR) of serious adverse events (SAEs) and common adverse events (CAEs) were estimated separately, as were predefined subgroups. Publication bias was evaluated by a funnel plot and Egger’s regression test.

Results

Among 978 reports, 99 full‐text articles were screened, and 20 articles were included for meta-analysis, involving 1132 patients (603 in the IMT group and 529 in the control group). We found no significant difference in the incidence of SAEs between the IMT group and the control group (RR = 1.36, 95% CI 0.56–3.31, P = 0.50). Of these 20 studies, 7 described the number of patients with CAEs, involving 360 patients (195 in the IMT group and 166 in the control group). An analysis of the eight studies revealed that the incidence of CAEs was also not significantly increased in the IMT group compared with the control group (RR = 1.06, 95% CI  0.91–1.23, P = 0.43). Subgroup analysis showed that the incidence of CAEs was significantly different between subgroups of delivery methods (P(CAE) = 0.04), and the incidence of IMT-related SAEs and CAEs was not significantly different in the other predefined subgroups.

Conclusion

Currently, IMT is widely used in many diseases, but its associated AEs should not be ignored. To improve the safety of IMT, patients' conditions should be fully evaluated before IMT, appropriate transplantation methods should be selected, each operative step of faecal bacteria transplantation should be strictly controlled, AE management mechanisms should be improved, and a close follow-up system should be established.
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Metadata
Title
Adverse events of intestinal microbiota transplantation in randomized controlled trials: a systematic review and meta-analysis
Authors
Chong Chen
Liyu Chen
Dayong Sun
Cailan Li
Shiheng Xi
Shihua Ding
Rongrong Luo
Yan Geng
Yang Bai
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Gut Pathogens / Issue 1/2022
Electronic ISSN: 1757-4749
DOI
https://doi.org/10.1186/s13099-022-00491-3

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