Oral capsules a viable delivery route for FMT in recurrent C. difficile infection
Use of oral capsules in the delivery of faecal microbiota transplantation (FMT) appears to be equally effective as colonoscopy in terms of preventing recurrent Clostridium difficile infection (RCDI) over 12 weeks, according to the results of a trial.
Specifically, in a cohort of 105 adults with RCDI (mean age 58 years; 68 percent female) who completed the trial, the primary endpoint of proportion of patients without recurrence at week 12 was 96.2 percent in both the capsule arm and the colonoscopy arm (51 of 53 vs 50 of 52; difference, 0 percent; p<0.001), meeting the criterion for noninferiority. [JAMA 2017;318:1985-1993]
In terms of secondary endpoints, one case of death due to underlying cardiopulmonary illness not associated with FMT was reported in each treatment arm. Minor adverse events occurred in 5.4 percent of patients in the capsule arm vs 12.5 percent in the colonoscopy arm.
Quality of life scores increased considerably following FMT treatment, with no significant difference between the two treatment arms. Meanwhile, significantly more patients in the capsule arm rated their experience as “not at all unpleasant” (66 percent vs 44 percent; difference, 22 percent; 95 percent CI, 3–40; p=0.01).
The investigators noted a higher success rate with FMT capsules in the current study than in previous ones. This rate is said to potentially indicate a benefit of bowel lavage prior to administering FMT, because residual vancomycin in the present cohort was detected up to 8 days despite its discontinuation. [JAMA 2014;312:1772-1778; JAMA 2016;315:142-149; Aliment Pharmacol Ther 2015;41:835-843]
“Currently, most patients with RCDI are referred to gastroenterology or infectious diseases, and the method and route in which FMT is administered are specialty dependent,” the investigators said.
“Although colonoscopy delivery is more invasive, resource intensive, costly and inconvenient for patients, it has the advantage of identifying alternative diagnoses. Conversely, when FMT is given by oral capsules, it can be administered in an office setting, which could substantially reduce cost and wait time,” they added, highlighting the need for comprehensive economic evaluations to further understand the value and efficacy of FMT by oral capsule.
Despite the presence of several limitations, the study demonstrates that treatment with oral capsules may be an effective approach to treating RCDI, the investigators said.
Tough pill to swallow
In an accompanying editorial, Dr Preeti N. Malani and colleagues from the University of Michigan Medical School in US noted that although the presented data on oral FMT capsules were promising and might facilitate increased adoption of FMT for RCDI, many broader questions about the efficacy of the treatment remains to be elucidated. [JAMA 2017;318:1979-1980]
The said questions involve acute RCDI, vancomycin taper duration, timing of FMT after RCDI onset and the relative importance of stool components.
“While it is encouraging that capsules appear to be a viable delivery route for FMT, a number of additional approaches still deserve consideration in future research. These include vancomycin tapers with and without “chasers” of fidaxomicin/ rifaximin, defined microbial communities, and sterile faecal-derived products. If these latter approaches prove to be effective, they may supplant standard FMT and other undefined microbial consortia, making even convenient, capsule-based FMT a tough pill to swallow,” Malani and colleagues wrote.