Safety, effectiveness of oral capsule FMT comparable to colonoscopy FMT

Administering faecal microbiota transplantation (FMT) orally via freeze dried capsules affords similar safety and effectiveness as FMT delivered via colonoscopy, but without the procedural risks associated with the latter, according to a study.

The analysis included 301 FMTs performed in 269 patients with recurrent Clostridioides difficile infection (rCDI) nonresponsive to standard therapy. Data on clinical outcomes and adverse events after FMT were drawn from a prospective registry.

FMT was performed using one of two standardized formulations of microbiota, namely freeze-dried/encapsulated or frozen-thawed/liquid, with the route of administration determined by the treating physician.

Researchers evaluated rCDI cure rate at 1 and 2 months. Safety data was collected within the first 72 hours and at 1 and 2 months. Logistic regression was used to investigate factors associated with FMT failure.

About two-thirds of the patients received capsule FMT. Overall CDI cure rates were 86 percent (95 percent confidence interval [CI], 82–90) at 1 month and 81 percent (95 percent CI, 75–86) at 2 months. There was no difference in the 1- or 2-month cure rates between capsule and colonoscopy FMT.

Of note, the patients who received capsule FMT recipients were older and less likely to be immunosuppressed or have inflammatory bowel disease. Older age and haemodialysis emerged as risk factors for FMT failure by 2 months on multivariate logistic regression. Additionally, post-FMT antibiotic use was associated with FMT failure at 2 months.

A single serious adverse event (aspiration pneumonia) was recorded in a colonoscopy FMT recipient, with the event related to the procedure. Aside from this, there were no new safety signals identified.

The findings highlight the importance of patient selection as a key factor to optimizing FMT success.