Clinical trials with 116 adults with recurrent C. difficile infection (rCDI), treated with oral capsules containing frozen donor bacteria was 96% effective, the same success rate as those receiving transplant by colonoscopy.
The capsules are made by processing faeces until bacteria remains, then encapsulating the bacteria concentrate inside three layers of gelatine capsule.
“Capsules have numerous advantages over colonoscopy,” said Dr Dina Kao, associate professor with the University of Alberta's faculty of medicine and dentistry and lead author of the study.
“They are non-invasive, they're less expensive, they don't have any of the risks associated with sedation and they can be administered in a doctor's office."
Dr Thomas Louie, clinical professor at the Cumming School of Medicine and the Calgary FMT study co-lead and senior author added that the pills were a “one-shot deal, not a continuing treatment",
"They are easier for patients and are well tolerated," she added.
FMT proving effective
Symptoms of C. difficile infections include diarrhoea, cramping and other gastrointestinal difficulties. In extreme cases, it may involve the removal of the large intestine. C. difficile can also prove resistant to antibiotic treatment.
Along with diet, antibiotics, probiotics and prebiotics, FMT is now considered a feasible treatment to address conditions linked to dysbiotic gut microbiome.
The diverse range of bacteria present in faecal matter is an advantage in treating chronic inflammatory diseases, insulin sensitivity as well as recurrent C. difficile infection.
Although FMT has proved effective, it’s not without its risks. While stools are carefully screened for known infectious agents, there is always a risk that the tests might fail to detect other pathogens.
Openbiome, a non-profit stool bank, active in FMT research for C.difficile infections provide hospitals across the US with screened, frozen material ready for clinical use.
Both the European Society for Microbiology and Infectious Disease and the American College of Gastroenterology recommend FMT as a treatment for rCDI.
Drs Louie and Kao began by randomized with 57 patients to the capsule group and 59 to the group receiving the single treatment via colonoscopy.
Prevention of rCDI was achieved in 96.2% in both the capsule group (51/53) and the colonoscopy group (50/52).
Rates of minor adverse events were 5.4% for the capsule group vs 12.5% for the colonoscopy group. There was no significant difference between the groups in improvement in quality of life.
Quality of life scores increased significantly for participants after FMT, with no significant difference between the treatment groups.
While 30% of participants described FMT as “unpleasant, gross or disgusting,” 97% indicated that they would undergo the treatment again if needed.
“Many people might find the idea of faecal transplantation off-putting, but those with recurrent infection are thankful to have a treatment that works," said Dr Louie.
“Recurrent C. difficile infection is such a miserable experience and patients are so distraught that many ask for faecal transplantation because they've heard of its success."
In an accompanying editorial, broader questions were raised regarding the efficacy of FMT.
One study evaluating FMT for rCDI compared 14 days of vancomycin, a more conventional treatment, in which subjects used a 1:1 allocation between treatment groups with the primary end-point being rCDI within 120 days.
The study was terminated due to futility after only 30 patients were randomised, with 58% of the vancomycin-only group remaining rCDI free compared with 44% in the FMT group.
Published online ahead of print: DOI: 10.1001/jama.2017.17077
“Effect of Oral Capsule– vs Colonoscopy-Delivered Fecal Microbiota Transplantation on Recurrent Clostridium difficile Infection.”
Authors: Thomas Louie et al