Improving regulation of microbiota transplants

Hoffmann, Diane E.; Palumbo, Francis B.; Ravel, Jacques; Roghmann, Mary-Claire; Rowthorn, Virginia; Rosenvinge, Erik C. von

doi:10.1126/science.aaq0034

Cited by 40 publications

(38 citation statements)

References 9 publications

(10 reference statements)

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“…Recent frameworks have promoted the need of easy access for patients to FMT as well as efficacy and safety data for regulators and providers. However, research in FMT beyond the indication of CDI remains limited …”

Section: Introductionmentioning

confidence: 99%

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Systematic review with meta‐analysis: review of donor features, procedures and outcomes in 168 clinical studies of faecal microbiota transplantation

Lai

Sung

Cheng

et al. 2019

Aliment Pharmacol Ther

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Summary Background Faecal microbiota transplantation (FMT) is effective for Clostridium difficile infections (CDI) refractory to standard treatment and is being studied in other diseases. Aim To evaluate donor characteristics, procedures and clinical outcomes of FMT. Methods We systematically reviewed FMT studies published up to 29 August 2018 using MEDLINE (R) and EMBASE and identified clinical studies with FMT donor information. We reported data on donor characteristics, screening criteria, administration, clinical outcomes and adverse events. Results Among 5267 reports, 239 full‐text articles were screened and 168 articles were included. FMT was performed commonly for CDI (n = 108) and inflammatory bowel disease (IBD) (n = 31). We reported characteristics of 1513 donors [58% male; mean age, 34.3 years; mean body mass index, 21.6]. Donors in Asia were younger than the West (mean age 30.7 vs 32.9, P = 0.00075). Less than 50% of studies screened donors for transmittable pathogens. Final cure rate for CDI was 95.6% (95% confidence interval [CI], 93.9%‐97.1%) and final remission rates for ulcerative colitis (UC) and Crohn's disease (CD) were 39.6% (95% CI, 25.4%‐54.6%) and 47.5% (95% CI, 29.4%‐65.8%), respectively. Cure rates in CDI and final remission rates for CD and UC were comparable across all routes of FMT administration. Overall adverse event incidence was <1%, mostly GI‐related. Adverse event rates did not differ significantly between routes of FMT administration or indication. Conclusions In a systematic review assessing donor characteristics and FMT efficacy, we observed heterogeneity in donor selection, application and outcomes of FMT. These data can facilitate standardisation of FMT protocols for various diseases.

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Section: Introductionmentioning

confidence: 99%

“…However, research in FMT beyond the indication of CDI remains limited. 9 Importantly, standardised FMT procedures are lacking, particularly on donor characteristics and selection. Although International recommendations exist for FMT, they are rarely implemented rigorously in practice.…”

Section: Introductionmentioning

confidence: 99%

Systematic review with meta‐analysis: review of donor features, procedures and outcomes in 168 clinical studies of faecal microbiota transplantation

Lai

Sung

Cheng

et al. 2019

Aliment Pharmacol Ther

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“…Adverse reactions include diarrhea, cramping, belching, constipation, and aspiration pneumonia in CDI patients and high fever in UC patients . The U.S. Food and Drug Administration (FDA) has issued regulations for physicians and fecal banks to regulate the use of therapeutic feces, but the definition of stool as a biological product is controversial, and the FDA has received substantial criticism due to consequent limited access to patients …”

Section: Gut Microbiota‐based Diagnosis and Therapiesmentioning

confidence: 99%

Gut microbiome interventions in human health and diseases

Nie

Wang

et al. 2019

Medicinal Research Reviews

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Ongoing studies have determined that the gut microbiota is a major factor influencing both health and disease. Host genetic factors and environmental factors contribute to differences in gut microbiota composition and function. Intestinal dysbiosis is a cause or a contributory cause for diseases in multiple body systems, ranging from the digestive system to the immune, cardiovascular, respiratory, and even nervous system. Investigation of pathogenesis has identified specific species or strains, bacterial genes, and metabolites that play roles in certain diseases and represent potential drug targets. As research progresses, gut microbiome–based diagnosis and therapy are proposed and applied, which might lead to considerable progress in precision medicine. We further discuss the limitations of current studies and potential solutions.

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“…At the same time, flexibility is required to ensure patient access to effective treatments, continuing innovation, and the investigation of new ideas. A European consensus that FMT is best regulated as a tissue transfer is emerging . While tissue transfer regulation may apply to unprocessed, donor‐specific, cryopreserved feces, the manipulation or standardization of feces into a well‐defined substance makes the resulting product ideal for the drug legislation .…”

Section: Perspectivementioning

confidence: 99%

Banking feces: a new frontier for public blood banks?

et al. 2019

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Fecal microbiota transplantation (FMT) is an effective treatment for recurrent Clostridioides difficile infection and is potentially beneficial in other microbiota-related disorders. The provision of FMT in routine clinical practice requires an extensive infrastructure that is reliant on voluntary donors. Alongside an increasing demand for FMT, the logistic barriers of a large-scale donor-dependent operation and the difficulties among health authorities to regulate FMT limit the dissemination of sustainable FMT services. Blood centers are large organizations that handle a multitude of donordependent operations on a daily basis. Blood and feces share many of the same dependencies, and feces may present a new opportunity for the blood services to handle. In this paper, we describe how an FMT service may be established and embedded within the blood service infrastructure, and we explain the benefits of using blood donors as feces donors. We further explore the current indications of FMT, the challenges related to the lack of legislation, and the future perspectives for blood banks to meet a new and increasing demand. ABBREVIATIONS: CD = Clostridioides difficile; EUTCD = European Tissue and Cells Directive; FMT = fecal microbiota transplantation; IND = investigational new drug; rCDI = recurrent Clostridioides difficile infection. From the

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Improving regulation of microbiota transplants

Abstract: Policy should balance safety, efficacy, access, and research

Cited by 40 publications

References 9 publications

Systematic review with meta‐analysis: review of donor features, procedures and outcomes in 168 clinical studies of faecal microbiota transplantation

Systematic review with meta‐analysis: review of donor features, procedures and outcomes in 168 clinical studies of faecal microbiota transplantation

Gut microbiome interventions in human health and diseases

Banking feces: a new frontier for public blood banks?

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