Editorial: Making Fecal Microbiota Transplantation Easier to Swallow: Freeze-Dried Preparation for Recurrent Clostridium difficile Infections

Abstract

Fecal microbiota transplant (FMT) has emerged as an effective and increasingly popular therapy for recurrent Clostridium diffi cile infections in patients that have failed standard antimicrobial treatment. Patient access to FMT is hampered by the logistics of manufacturing, storing, and delivering the inocula. An observational study describes the development and clinical effi cacy of freeze-dried FMT capsules for oral administration. While awaiting the emergence of defi ned bacterial therapeutics for Clostridium diffi cile infections, this refi nement of FMT is an encouraging step toward simplifying FMT treatment. Randomized controlled trials are required to further establish the effi cacy and safety of lyophilized FMT. Am J Gastroenterol 2017; 112:948-950; doi: 10.1038/ajg.2017 In recent years, as the important roles of gut microbiota in human physiology are coming to light, fecal microbiota transplantation (FMT), i.e., the transfer of fecal microbes from a donor to a patient, has emerged as an eff ective and increasingly popular therapy for recurrent Clostridium diffi cile infections (CDI) ( 1 ). Th e evolving epidemiology of CDI has focused interest on "non-traditional" treatment modalities, as the disease has established itself as a major cause of both healthcare and communityacquired morbidity and mortality ( 2 ). Suboptimal response to standard antimicrobial treatment with metronidazole, vancomycin, and even fi daxomicin is common, resulting in CDI recurrences in up to 30% of patients ( 3 ). Initial CDI recurrences are followed by even higher recurrence rates. Prolonged vancomycin taper/pulse therapy is oft en administered and is up to 58% eff ective in this multiple recurrence population ( 4 ), leaving a growing number of patients and providers in search of alternative treatment options. Although not an U.S. Food and Drug Administration-approved treatment, randomized controlled trials are being increasingly reported ( 4-9 ) and generally show success rates (prevention of further recurrent CDI) of 70% or greater, although rates for a single FMT via the enema route are lower if a modifi ed intent-to-treat (mITT) end point is used ( 4,9 ). Despite lack of U.S. Food and Drug Administration approval, FMT has rapidly become an accepted treatment for recurrent CDI that has not responded to standard treatments. Most offi cial treatment guidelines of gastroenterology and infectious diseases associations in the US, Canada, Europe, and Australia include FMT as at least an alternative therapy.Nevertheless, access to FMT is still hampered by the logistics of donor selection and screening, processing of the inoculum, and delivery to the colon. In the past 2 years, several important advances have been made in an eff ort to make FMT accessible to a wider population of patients. First, though frozen FMT has been used for some time, it was only recently that Lee et al. ( 9 ) showed clinical non-inferiority in a randomized controlled study using enemas, although response rates varied widely depending upon the num...

Role of fecal microbiota transplantation in inflammatory bowel disease

“…In a recent study by Zhang et al, a novel colonic transendoscopic enteral tubing approach was tested with the aim of reducing the necessity for repeated endoscopies in the case of several administrations of FMT. In addition, microbiota‐based capsules are currently under evaluation in clinical trials for a number of different conditions, including IBD . It is hoped that these efforts will lead to the refinement of synthetic stool that may have a beneficial effect in IBD .…”

“…In addition, microbiota-based capsules are currently under evaluation in clinical trials for a number of different conditions, including IBD. 52 It is hoped that these efforts will lead to the refinement of synthetic stool that may have a beneficial effect in IBD. 50 Pharmaceutical advances, however, cannot be separated from intricate studies of the complex interplay between host and donor microbiota, both at baseline and after FMT.…”

Gut Microbiota and Salivary Diagnostics: The Mouth Is Salivating to Tell Us Something

“…The hope is that such bacterial preparations will be successful in treating various conditions, including C. difficile infection. 103 , 105 , 106 The composition of fecal microbiota as a valid surrogate representation of the eubiotic (normal) gut microbiome system aimed to be reconstituted 71 , 103 , 104 , 107 , 108 is also gaining greater scrutiny, 104 , 109 particularly if antibiotics were taken within 12 months before stool collection. 98 Indeed, because of resulting alterations in a patient's microbiome, the impact of antibiotics on the life-saving potential of powerful new therapeutic approaches, including immuno-oncology checkpoint inhibitors and other state-of-the-art immune system modulators, is currently a hot topic in medical practice.…”

Protocol for a double-blind, randomised, placebo-controlled pilot study for assessing the feasibility and efficacy of faecal microbiota transplant in a paediatric Crohn’s disease population: PediCRaFT Trial

“…No defined protocols exist in the literature, and the use of combination oral and colonoscopic FMT infusions has not been previously tested. Oral FMT preparations are being increasingly used in clinical trials43–46 and offered through industry 47 48. These preparations may be easier to administer than rectal enema or endoscopic infusion and may be particularly amenable to serial administration.…”