Faecal microbiota transplant for recurrent<i>Clostridium difficile</i>infection using long-term frozen stool is effective: clinical efficacy and bacterial viability data

Costello, Samuel P; Conlon, Michael A.; Vuaran, Michelle S.; Ic, Roberts-Thomson; Andrews, Jane M.

doi:10.1111/apt.13366

Cited by 122 publications

(118 citation statements)

References 33 publications

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“…However, there have been no comparative trials investigating storage durations. As already described, a reduction in the viability of certain gut microbiota taxa was noted when faecal aliquots were frozen in 10% glycerol for 6 months74 and, as such, the working group agreed that 6 months was the acceptable limit for freezing of an FMT in glycerol. Storage at −80°C is recommended rather than −20°C to minimise sample degradation.…”

Section: Rationale For Recommendationssupporting

confidence: 56%

“…Colonoscopic delivery of donor FMT into the ileum or caecum was associated with a 91% cure rate for recurrent CDI 14. Observational studies highlighted similar success, describing cure rates of 88% (n=14/16)74 and 91%46 (n=21/23) in response to infusion of donor FMT into the caecum or terminal ileum. A further advantage of using colonoscopy to administer FMT has been to allow assessment for the presence of pseudomembranes; in certain reviewed studies, the presence or absence of pseudomembranes has influenced the FMT regimen used 18 73.…”

Section: Rationale For Recommendationsmentioning

confidence: 87%

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The use of faecal microbiota transplant as treatment for recurrent or refractoryClostridium difficileinfection and other potential indications: joint British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS) guidelines

Mullish

Quraishi

Segal

et al. 2018

Gut

278

187

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Interest in the therapeutic potential of faecal microbiota transplant (FMT) has been increasing globally in recent years, particularly as a result of randomised studies in which it has been used as an intervention. The main focus of these studies has been the treatment of recurrent or refractory infection (CDI), but there is also an emerging evidence base regarding potential applications in non-CDI settings. The key clinical stakeholders for the provision and governance of FMT services in the UK have tended to be in two major specialty areas: gastroenterology and microbiology/infectious diseases. While the National Institute for Health and Care Excellence (NICE) guidance (2014) for use of FMT for recurrent or refractory CDI has become accepted in the UK, clear evidence-based UK guidelines for FMT have been lacking. This resulted in discussions between the British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS), and a joint BSG/HIS FMT working group was established. This guideline document is the culmination of that joint dialogue.

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Section: Rationale For Recommendationssupporting

confidence: 56%

Section: Rationale For Recommendationsmentioning

confidence: 87%

The use of faecal microbiota transplant as treatment for recurrent or refractoryClostridium difficileinfection and other potential indications: joint British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS) guidelines

Mullish

Quraishi

Segal

et al. 2018

Gut

278

187

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“…Under the universal donor model, providers are responsible only for performing the procedure itself. Stool preparations can be cryogenically preserved without decreasing their effectiveness 12 and stored in health care facilities across Canada to avoid treatment delays.…”

Section: Key Pointsmentioning

confidence: 99%

Seeking safe stool: Canada needs a universal donor model

Edelstein

Daw

Kassam

2015

CMAJ

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E arly in 2015, Health Canada opened the door to fecal microbiota transplantation, a promising treatment for patients with recurrent Clostridium difficile infection.1 During fecal microbiota transplantation, stool from a healthy, screened donor is homogenized and filtered and is either infused into the patient by means of colonoscopy, nasoenteric tube or enema, or taken orally in an encapsulated formulation. The procedure restores the diversity of gut microbiota that confers protection against recurrent C. difficile infection. 2 The results are remarkable: the first randomized controlled trial of the procedure for recurrent C. difficile infection was stopped early because of benefit, 3 and a high-quality meta-analysis reported an 89% clinical cure rate.2 Accordingly, medical societies and national health regulators such as the American College of Gastroenterology and the UK National Institute for Health and Care Excellence have adopted fecal microbiota transplantation as part of their guidelines. 4Fecal microbiota transplantation represents a novel approach for managing recurrent C. difficile infection.2,5 Clostridium difficile infection is among the most common health care-associated infections in Canada and costs more than $280 million annually. 6 The incidence has increased over the past decade, reaching an estimated 37 900 episodes in 2012, with a corresponding rise in mortality.7 With antibiotics, a patient's risk of recurrent infection is 20% after a primary episode and more than 60% after two recurrences.2 The disease burden, combined with fecal microbiota transplantation's relative effectiveness, has catalyzed rapid clinical adoption of the procedure in other countries. The new Health Canada guidance now permits fecal microbiota transplantation outside of clinical trials for Canadians with recurrent C. difficile infection.Although a welcome shift, the policy supports a model for delivering fecal microbiota transplantation that undermines its potential benefits. The guidance limits the procedure to a directed donor model, which requires the patient or physician to identify a stool donor (e.g., spouse). This model places responsibility on physicians for donor screening, material preparation, administration and monitoring for adverse events. By contrast, the universal donor model, currently allowed in the United States, 4 makes use of de-identified donors who are screened by a stool bank. Much like blood banks, stool banks provide a standardized and scalable product, and an adverse events registry. We evaluate these two models along the dimensions of patient safety, access to the procedure and cost to the health care system (Appendix 1, available at www.cmaj .ca/lookup/suppl/ doi:10.1503/cmaj.150672/-/DC1).First, although fecal microbiota transplantation has shown remarkable therapeutic benefit, its safety profile includes both procedure-related (e.g., colonoscopy-induced perforation) and material-related risks.4 Prospective long-term safety studies are ongoing, but no adverse events related to material use...

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“…It was shown that preserved slurries with or without glycerol exhibited remission rates similar to fresh FMT. Furthermore, only minor viability drops in the tested cultivable anaerobes over 6 months of frozen storage were reported (van Nood et al ., 2013; Youngster et al ., 2014; Costello et al ., 2015; Satokari et al ., 2015). However, artificially produced microbiota may lack the protective effect of a matrix naturally present in stool.…”

Section: Introductionmentioning

confidence: 99%

Cryopreservation of artificial gut microbiota produced with in vitro fermentation technology

Bircher

Schwab

Geirnaert

et al. 2017

Microbial Biotechnology

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SummaryInterest in faecal microbiota transplantation (FMT) has increased as therapy for intestinal diseases, but safety issues limit its widespread use. Intestinal fermentation technology (IFT) can produce controlled, diverse and metabolically active ‘artificial’ colonic microbiota as potential alternative to common FMT. However, suitable processing technology to store this artificial microbiota is lacking. In this study, we evaluated the impact of the two cryoprotectives, glycerol (15% v/v) and inulin (5% w/v) alone and in combination, in preserving short‐chain fatty acid formation and recovery of major butyrate‐producing bacteria in three artificial microbiota during cryopreservation for 3 months at −80°C. After 24 h anaerobic fermentation of the preserved microbiota, butyrate and propionate production were maintained when glycerol was used as cryoprotectant, while acetate and butyrate were formed more rapidly with glycerol in combination with inulin. Glycerol supported cryopreservation of the Roseburia spp./Eubacterium rectale group, while inulin improved the recovery of Faecalibacterium prausnitzii. Eubacterium hallii growth was affected minimally by cryopreservation. Our data indicate that butyrate producers, which are key organisms for gut health, can be well preserved with glycerol and inulin during frozen storage. This is of high importance if artificially produced colonic microbiota is considered for therapeutic purposes.

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Faecal microbiota transplant for recurrentClostridium difficileinfection using long-term frozen stool is effective: clinical efficacy and bacterial viability data

Cited by 122 publications

References 33 publications

The use of faecal microbiota transplant as treatment for recurrent or refractoryClostridium difficileinfection and other potential indications: joint British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS) guidelines

The use of faecal microbiota transplant as treatment for recurrent or refractoryClostridium difficileinfection and other potential indications: joint British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS) guidelines

Seeking safe stool: Canada needs a universal donor model

Cryopreservation of artificial gut microbiota produced with in vitro fermentation technology

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