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Updated: Sep 21, 2025
Therapeutic Evaluation of Fecal Microbiota Transplantation in an Interleukin 10-Deficient Mouse Model
Published on: April 6, 2022
Adverse events of intestinal microbiota transplantation in randomized controlled trials: a systematic review and
Chong Chen1, Liyu Chen2, Dayong Sun1
1Department of Gastroenterology, The First Affiliated Hospital of Shenzhen University, Shenzhen Second People's Hospital, Shenzhen, 518037, China.
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.
Insights
Intestinal microbiota transplantation (IMT) is a promising treatment, but its safety requires attention. This review found no significant increase in serious or common adverse events compared to control groups, suggesting IMT is generally safe.
Area of Science:
- Gastroenterology and Hepatology
- Microbiology
- Clinical Trials and Epidemiology
Background:
- Intestinal microbiota transplantation (IMT) shows promise for treating recurrent Clostridium difficile infection (rCDI) and other conditions.
- However, comprehensive data on the safety of IMT in clinical practice remains limited.
Purpose of the Study:
- To systematically review and meta-analyze randomized controlled trials (RCTs) assessing the safety of IMT.
- To evaluate the incidence of serious adverse events (SAEs) and common adverse events (CAEs) associated with IMT.
Main Methods:
- A systematic literature search of PubMed, EMBASE, and Cochrane Library was conducted for RCTs up to February 2021.
- Studies reporting adverse events were included; data extraction and analysis of SAEs and CAEs were performed.
- Publication bias was assessed using funnel plots and Egger's regression test.
Main Results:
- Twenty RCTs involving 1132 patients (603 IMT, 529 control) were included.
- No significant difference in SAEs (RR=1.36, P=0.50) or CAEs (RR=1.06, P=0.43) was observed between IMT and control groups.
- Subgroup analysis indicated a significant difference in CAE incidence based on delivery methods (P=0.04).
Conclusions:
- Current evidence suggests IMT is not associated with a significant increase in overall SAEs or CAEs.
- However, careful patient selection, appropriate method selection, strict procedural control, and robust AE monitoring are crucial for optimizing IMT safety.
- Further research and established AE management protocols are recommended for widespread IMT application.
