Effective Solution for Recurrent C. Difficile Infections

In a recent study published in the Cochrane Database of Systematic Reviews, researchers provide insight into fecal microbiota transplantation (FMT) in the treatment of recurrences Clostridioides difficile infection (rCDI).

Study: Fecal Microbiota Transplantation for the Treatment of Clostridioides Difficile (Clostridium Difficile) Recurrence. Image Credit: Prrrettty / Shutterstock.com

Treat CDI

It’s hard, a bacterial organism, can repeatedly cause life-threatening diarrhea when infecting individuals with microbial dysbiosis. The conventional approach to treating CDI includes antibiotics, which could further aggravate gut microbial alterations.

FMT can also be used to manage CDI by restoring balance to the gut microbiome. Nevertheless, further research, including randomized controlled trials (RCTs), is needed to assess the benefit/risk ratio of TMF for the management of rICD.

About the study

In this systematic review, researchers examine the existing data on FMT as a management option for rCDI compared to conventional treatment approaches, including antibiotics.

The team used standard and extended Cochrane methods to search for relevant data up to 31 March 2022. Only RCTs, including pediatric and/or adult patients with rCDI, provided interventions that met the criteria for the FMT, which involve the administration of distal gut microbiome donor feces into the gastrointestinal (GI) tract of patients with rCDI, were included.

Other treatment groups included those who received placebo therapies, no therapeutic intervention, autologous FMT, or antibiotics to treat CDI.

The primary outcomes of the study were the percentage of individuals with resolution of CDI and serious-type adverse events. Secondary outcomes of the study included treatment failure, death from any cause, withdrawal from the study, recurrence rate of CDI infections after FMT, adverse events, quality of life and colectomy rates.

The quality of the evidence was assessed using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) approach. The Risk of Bias 2 (RoB 2) tool was used to assess risk of bias in the included studies. In addition, the relative risks (RR) and the number needed to treat for an additional beneficial outcome (NNTB) were calculated.

Results

A total of six RCTs were considered for the final review, which included 320 adults. These trials were conducted in several countries, including Italy, Denmark, the Netherlands, the United States and Canada.

Four RCTs were performed at a single center, while two RCTs were performed at multiple centers. Only one RCT included immunocompromised people who were evenly split between intervention (FMT) and comparison (non-FMT) groups.

In one RCT, FMT was administered through the upper gastrointestinal tract using nasoduodenal tubes. Comparatively, two RCTs involved the administration of FMT enema, and two others involved the administration of colonoscopic FMT. In one RCT involving colonoscopic or nasojejunal administration of donor feces, the choice of administration was based on an individual’s colonoscopic tolerance.

Five records included one or more comparison groups receiving vancomycin. Risk of bias was not high for any of the study outcomes.

The security and efficiency of FMT in the treatment of rCDI was assessed in all included RCTs. Pooled data from all studies indicated that FMT was likely to increase the resolution of rCDI in immunocompetent individuals compared to controls.

The RR and NNTB values ​​were 1.9 and 3.0, respectively. The quality of the evidence was rated as moderate in the included studies.

Importantly, FMT resulted in a marginal decrease in serious adverse events; however, these observations were associated with wide confidence interval (CI) estimates, including RR and NNTB values ​​of 0.7 and 12, respectively, indicating a moderate certainty of this evidence.

All-cause death, which was only assessed from a few events, was reduced after FMT, with RR and NNTB values ​​of 0.6 and 20, respectively. The certainty of the evidence was low for this conclusion.

Colectomy rates were not documented in any of the RCTs. Eliminating the RCT that included immunocompromised people gave similar results.

conclusion

Based on these findings, in immunocompetent and adult patients with rCDI, FMT is more likely to resolve rCDI than alternative therapies, including antibiotics. Only a few adverse events and all-cause deaths have been reported; therefore, no conclusive evidence on the safety of FMT could be obtained.

Further research, including analysis of data documented in large-scale and national registries, is needed to assess the acute and chronic risks associated with the administration of FMT in patients with rCDI. Future studies should also assess the therapeutic effects of FMT in immunocompromised people in order to design health policies and strategies accordingly and prioritize those most likely to benefit from the therapy.