Multidonor intensive faecal microbiota transplantation for active ulcerative colitis: a randomised placebo-controlled trial

Paramsothy, Sudarshan; Kamm, Michael A.; Kaakoush, Nadeem O.; Walsh, Alissa J.; Bogaerde, Johan van den; Samuel, Douglas B.; Leong, Rupert W.; Connor, Susan J.; Ng, Watson; Paramsothy, Ramesh; Xuan, Wei; Lin, Enmoore; Mitchell, Hazel M.; Borody, Thomas J.

doi:10.1016/s0140-6736(17)30182-4

Cited by 1,017 publications

(1,081 citation statements)

References 28 publications

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“…The low remission rate and low engraftment may be due to the fact that the transplantation was performed with a single donor and not with a multidonor approach, as described in a recent FMT study in patients with UC [21]. The Food and Drug Agency (FDA) investigational new drug application, which is necessary for every clinical study in the USA and authorizes the administration of an investigational drug or biological product to humans, did not allow the use of a multidonor approach for the endoscopic and capsulated FMT in our study.…”

Section: Discussionmentioning

confidence: 99%

Combined Endoscopic and Oral Fecal Microbiota Transplantation in Patients with Antibiotic-Dependent Pouchitis: Low Clinical Efficacy due to Low Donor Microbial Engraftment

et al. 2019

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Background and Objective: A significant number of pouch patients develop antibiotic-dependent pouchitis (ADP). Microbial dysbiosis is thought to be a major driver of clinical symptoms in ADP. The objective of this proof of concept study was to evaluate safety, efficacy, and donor microbial engraftment of an intensified fecal microbiota transplant (FMT) consisting of a single endoscopic FMT followed by daily oral FMT for 2 weeks in patients with ADP. Methods: We performed a prospective placebo-controlled double-blind FMT trial in patents with established ADP and planned to enroll 20 patients in this proof of concept study. In case of non-response, patients were offered an optional open label active FMT treatment. The endpoints were safety, clinical remission without need for antibiotics during 16 weeks of follow-up, quantitative changes of fecal calprotectin (FCP), and engraftment of donor FMT as determined by metagenomic sequencing of the V4 region of the 16S rRNA gene. Results: Due to a lower than expected clinical remission rate and low FMT engraftment, enrollment in the study was stopped prematurely after 6 patients were included. All 6 patients enrolled in the placebo-controlled portion failed to respond and needed antibiotic rescue therapy shortly after FMT. FCP increased in the majority of patients in the setting of relapse after FMT. In the active open label FMT extension study 1 out of 5 patients achieved antibiotic-free clinical remission. FMT engraftment after active FMT was observed only in this single patient, whereas engraftment of donor FMT occurred in none of the other patients receiving active FMT, paralleling the lack of clinical response. Conclusions: Low donor FMT engraftment resulted in low clinical efficacy of FMT in patients with ADP. Before embarking on larger clinical trials with FMT in patients with ADP or other forms of pouchitis, it is mandatory to explore approaches for superior FMT engraftment.

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Section: Discussionmentioning

confidence: 99%

Combined Endoscopic and Oral Fecal Microbiota Transplantation in Patients with Antibiotic-Dependent Pouchitis: Low Clinical Efficacy due to Low Donor Microbial Engraftment

et al. 2019

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“…In a recent randomized, placebo-controlled clinical trial, individuals with ulcerative colitis who received FMT were threetimes more likely to have a steroid-free clinical remission with endoscopic remission or response than those assigned to placebo, but a low absolute number of individuals (27% of intervention) responded to the FMT [20]. Additionally, there have been initial anecdotal results describing the use of FMT for the elimination of multidrugresistant organisms, which colonize the intestinal microbiota.…”

Section: Microbiota-based Interventionsmentioning

confidence: 99%

The Microbiome: Current and Future view of an Ancient Paradigm

et al. 2017

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“…Für andere Indikationen als die rCDI besteht bis anhin noch keine ausreichende wissenschaftliche Evidenz. Am Vielversprechendsten sind momentan erste Resultate bei der Colitis ulcerosa, wenngleich bisher nicht verstanden ist, warum nur manche Patienten profitieren und warum spezifische Donoren mit deutlich höheren Erfolgsraten assoziiert zu sein scheinen [38][39][40].…”

Section: Fazit Und Ausblickunclassified

«Mikrobiota-Tuning» en vogue: Von der Ernährung über Probiotika bis zur fäkalen Mikrobiota-Transplantation

Biedermann

Rogler

Zeitz

2017

Schweiz Z Ganzheitsmed

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Multidonor intensive faecal microbiota transplantation for active ulcerative colitis: a randomised placebo-controlled trial

Cited by 1,017 publications

References 28 publications

Combined Endoscopic and Oral Fecal Microbiota Transplantation in Patients with Antibiotic-Dependent Pouchitis: Low Clinical Efficacy due to Low Donor Microbial Engraftment

Combined Endoscopic and Oral Fecal Microbiota Transplantation in Patients with Antibiotic-Dependent Pouchitis: Low Clinical Efficacy due to Low Donor Microbial Engraftment

The Microbiome: Current and Future view of an Ancient Paradigm

«Mikrobiota-Tuning» en vogue: Von der Ernährung über Probiotika bis zur fäkalen Mikrobiota-Transplantation

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