Stability and efficacy of frozen and lyophilized fecal microbiota transplant (FMT) product in a mouse model of Clostridium difficile infection (CDI)

Jiang, Zhi‐Dong; Alexander, Ashley; Shi, Ke; Valilis, Evangelia; Hu, Shaofan; Li, Bingjie; DuPont, Herbert L.

doi:10.1016/j.anaerobe.2017.08.003

Cited by 39 publications

(25 citation statements)

References 25 publications

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“…In a previous study, fecal aliquots were frozen in 10% glycerol resulting in constant number of viable and culturable bacteria for 2 to 6 months (3). Working with the frozen and lyophilized product used in the present study, we found both products active in preventing CDI in a mouse model up to 7 months after storage of, frozen product at -80 o C and lyophilized product at standard refrigerator temperature (~1.6 o C) [ 21 ].…”

Section: Discussionmentioning

confidence: 99%

Safety and preliminary efficacy of orally administered lyophilized fecal microbiota product compared with frozen product given by enema for recurrent Clostridium difficile infection: A randomized clinical trial

et al. 2018

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BackgroundFecal microbiota transplantation (FMT) via colonoscopy or enema has become a commonly used treatment of recurrent C. difficile infection (CDI).AimsTo compare the safety and preliminary efficacy of orally administered lyophilized microbiota product compared with frozen product by enema.MethodsIn a single center, adults with ≥ 3 episodes of recurrent CDI were randomized to receive encapsulated lyophilized fecal microbiota from 100–200 g of donor feces (n = 31) or frozen FMT from 100 g of donor feces (n = 34) by enema. Safety during the three months post FMT was the primary study objective. Prevention of CDI recurrence during the 60 days after FMT was a secondary objective. Fecal microbiome changes were examined in first 39 subjects studied.ResultsAdverse experiences were commonly seen in equal frequency in both groups and did not appear to relate to the route of delivery of FMT. CDI recurrence was prevented in 26 of 31 (84%) subjects randomized to capsules and in 30 of 34 (88%) receiving FMT by enema (p = 0.76). Both products normalized fecal microbiota diversity while the lyophilized orally administered product was less effective in repleting Bacteroidia and Verrucomicrobia classes compared to frozen product via enema.ConclusionsThe route of delivery, oral or rectal, did not influence adverse experiences in FMT. In preliminary evaluation, both routes appeared to show equivalent efficacy, although the dose may need to be higher for lyophilized product. Spore-forming bacteria appear to be the most important engrafting organisms in FMT by the oral route using lyophilized product.Trial registrationClinicalTrials.gov NCT02449174

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Section: Discussionmentioning

confidence: 99%

Safety and preliminary efficacy of orally administered lyophilized fecal microbiota product compared with frozen product given by enema for recurrent Clostridium difficile infection: A randomized clinical trial

et al. 2018

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“…However, Jiang et al . () reported that effectiveness was retained only for up to 7 months at −80°C. It is likely that the optimal storage time will be lost more quickly at −20°C, as shown in our study.…”

Section: Discussionmentioning

confidence: 99%

“…A number of practical factors are known to affect the outcome of FMT, including fresh or frozen faeces (Jiang et al 2017), single or multiple challenging (He et al 2017), antibiotic therapy prior to FMT (Ishikawa et al 2017). Fresh FMT has some difficulties in preparing fresh material.…”

Section: Discussionmentioning

confidence: 99%

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Faecal freezing preservation period influences colonization ability for faecal microbiota transplantation

et al. 2019

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Aims There has been growing interest in faecal microbiota transplantation (FMT) as treatment. Although, frozen donor faeces preserved at −20°C has been widely used for practical advantages, freezing at −20°C can affect bacterial viability. Adequacy evaluation of fresh and frozen faeces as the transplant is necessary for the methodological improvement of FMT. Methods and Results The viable bacterial compositions of faecal specimens under fresh and freezing conditions were compared by a microbiome analysis using propidium monoazide (PMA microbiome). In addition, recovery abilities from bacterial reduction by antibiotics were compared between fresh and frozen FMT using a murine model. PMA microbiome results suggested that freezing and freeze‐thawing did not significantly affect in vitro faecal bacterial viability. However, the recovery effect from antimicrobial cleansing in frozen FMT was reduced in a freezing time‐dependent manner, especially prominent in Actinobacteria and Bacteroidetes phyla. Conclusions Short‐term freezing preservation of faeces exhibited maintenance of enteric colonization ability in frozen FMT in comparison to 1 month −20°C‐preservation. Significance and Impact of the Study Long‐term −20°C‐preservation of transplanted faeces can result in instability of the clinical outcome in FMT therapy. The standardization of practical procedures of FMT therapy according to disease types is desirable.

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“…Beyond this time frame, the product was determined to be unstable. 50 Another study treating human subjects with frozen fecal matter determined stability of the product when frozen in 10% glycerol for up to 6 months; however, efficacy was maintained in treatment of stool frozen for up to 10 months for rCDI. 51 A study published in 2016 looked at fecal samples that had been freeze-dried and then frozen over a 14-year period in a −20°C freezer.…”

Section: Stool Preparationmentioning

confidence: 99%

Fecal Transplant: How an Ancient Therapy Is Finding a New Use in Today’s Antibiotic-Resistant Era

McBeth¹,

Dobner²

2019

JRM

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Fecal transplant refers to any method of delivery of healthy human stool to the colon of a recipient. This therapy is now gaining standard-of-care designation in the United States, Australia, and many parts of Europe for treating resistant Clostridium difficile infection). This literature review describes fecal transplant protocols. It highlights the variety of techniques used to screen stool donors; prepare and deliver treatment; and how, despite these variations, safety and efficacy remain high. It highlights the various ways to best mitigate safety while also recommending the direction in which clinical and research communities can move to continue to provide access to fecal microbiota transplant in a cost-effective manner.

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Stability and efficacy of frozen and lyophilized fecal microbiota transplant (FMT) product in a mouse model of Clostridium difficile infection (CDI)

Cited by 39 publications

References 25 publications

Safety and preliminary efficacy of orally administered lyophilized fecal microbiota product compared with frozen product given by enema for recurrent Clostridium difficile infection: A randomized clinical trial

Safety and preliminary efficacy of orally administered lyophilized fecal microbiota product compared with frozen product given by enema for recurrent Clostridium difficile infection: A randomized clinical trial

Faecal freezing preservation period influences colonization ability for faecal microbiota transplantation

Fecal Transplant: How an Ancient Therapy Is Finding a New Use in Today’s Antibiotic-Resistant Era

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