Donor Efficacy in Fecal Microbiota Transplantation for Recurrent Clostridium difficile: Evidence From a 1,999-Patient Cohort

Osman, Majdi; Stoltzner, Zachery; OʼBrien, Kelsey; Ling, Kelly; Koelsch, Emily; Dubois, Nancy; Amaratunga, Kanchana; Smith, Mark; Kassam, Zain

doi:10.1093/ofid/ofw194.48

Cited by 26 publications

(25 citation statements)

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“…In cohorts of patients who have undergone FMT to treat CDI, the choice of donor does not have an important impact on the efficacy of therapy . Similarly, it seems that neither anaerobic vs aerobic stool preparation, nor fresh or frozen stool, significantly influences the efficacy of FMT for CDI .…”

Section: Discussionmentioning

confidence: 99%

Systematic review with meta‐analysis: faecal microbiota transplantation for the induction of remission for active ulcerative colitis

Costello

Soo

Bryant

et al. 2017

Aliment Pharmacol Ther

226

162

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Section: Discussionmentioning

confidence: 99%

Systematic review with meta‐analysis: faecal microbiota transplantation for the induction of remission for active ulcerative colitis

Costello

Soo

Bryant

et al. 2017

Aliment Pharmacol Ther

226

162

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“…The optimal donor stool for FMT is still uncertain. In cohorts of patients who have undergone FMT to treat CDI, the choice of donor does not have an important impact on the efficacy of therapy [ 52 ]. In the present study, donor stools were from healthy adults or children family members or close friends or volunteers.…”

Section: Discussionmentioning

confidence: 99%

Protocol for Fecal Microbiota Transplantation in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis

Hou

Lian

Wang

2018

BioMed Research International

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Background Fecal microbiota transplantation (FMT) is an emerging treatment approach for inflammatory bowel disease (IBD). The donor selection, the separation of fecal bacteria, the frequency of FMT, the way of infusion, the long-term safety, and efficacy are still uncertain. Aim To further study the efficacy and safety and protocol of FMT for IBD. Methods A systematic review and meta-analysis were conducted until February, 2018. Clinical remission was established as the primary outcome. Results A total of 596 paediatric and adult IBD patients were enrolled, and 459 patients received FMT therapy. 28.8% (132/459) patients achieved clinical remission during follow-up. 53% (241/459) patients achieved clinical response. The pooled estimated clinical remission for ulcerative colitis (UC) was 21% (95% CI: 8%-37%) and 30% (95% CI: 11%-52%) for Crohn's disease (CD), both with a risk of heterogeneity; 10% (95% CI: 0%-43%) for paediatric UC; 26% (95% CI: 10%-48%) for adult UC; 45% for paediatric CD (95% CI: 24%-66%); 22% (95% CI: 3%-52%) for adult CD. Meta-analysis of cohort studies showed that moderate-severe IBD patients could achieve more significant remission from FMT than mild-moderate patients (P=0.037). Delivery route has no impact on the efficacy of FMT in UC and CD. Based on current available evidence, a trend was observed towards higher clinical remission rate of frozen stool FMT than that of fresh stool for UC, while there was no significant difference between fresh and frozen FMT for CD. The optimal donor stool for FMT is still uncertain. Meta-analysis of RCTs showed that FMT treatment achieved significantly higher clinical remission rate than placebo for UC (28% versus 9%, P=0.0003). Conclusion FMT is an effective and safe therapy for both paediatric and adult IBD; fresh or frozen donor stool, delivery route, and antibiotic pretreatment or not have no impact on the efficacy of FMT in IBD. FMT might be a potential rescue therapy and even an initial standardized therapy for IBD. However, few data exist on long-term safety and efficacy and further validation is needed.

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“…https://doi.org/10.1101/19000307 doi: medRxiv preprint sufficient. Indeed, FMT trials have demonstrated that rCDI can be effectively treated by almost any choice of healthy donor (Osman et al 2016). In this case, researchers should consider how they define a "healthy" microbiome and how they will ensure clinical efficacy, for example through engraftment of the transplanted healthy communities.…”

Section: Acute Dysbiosismentioning

confidence: 99%

Framework for rational donor selection in fecal microbiota transplant clinical trials

Duvallet

Zellmer

Panchal

et al. 2019

Preprint

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Early clinical successes are driving enthusiasm for fecal microbiota transplantation (FMT), the transfer of healthy gut bacteria through whole stool, as emerging research is linking the microbiome to many different diseases. However, preliminary trials have yielded mixed results and suggest that heterogeneity in donor stool may play a role in patient response. Thus, clinical trials may fail because an ineffective donor was chosen rather than because FMT is not appropriate for the indication. Here, we describe a conceptual framework to guide rational donor selection to increase the likelihood that FMT clinical trials will succeed. We argue that the mechanism by which the microbiome is hypothesized to be associated with a given indication should inform how healthy donors are selected for FMT trials, categorizing these mechanisms into four disease models and presenting associated donor selection strategies. We next walk through examples based on previously published FMT trials and ongoing investigations to illustrate how donor selection might occur in practice. Finally, we show that typical FMT trials are not powered to discover individual taxa mediating patient responses, suggesting that clinicians should develop targeted hypotheses for retrospective analyses and design their clinical trials accordingly. Moving forward, developing and applying novel clinical trial design methodologies like rational donor selection will be necessary to ensure that FMT successfully translates into clinical impact.

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Donor Efficacy in Fecal Microbiota Transplantation for Recurrent Clostridium difficile: Evidence From a 1,999-Patient Cohort

Cited by 26 publications

References 0 publications

Systematic review with meta‐analysis: faecal microbiota transplantation for the induction of remission for active ulcerative colitis

Systematic review with meta‐analysis: faecal microbiota transplantation for the induction of remission for active ulcerative colitis

Protocol for Fecal Microbiota Transplantation in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis

Framework for rational donor selection in fecal microbiota transplant clinical trials

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