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Donated stool for faecal microbiota transplantation is not a drug, but guidance and regulation are needed.
Keller JJ, Vehreschild MJ, Hvas CL, Jørgensen SM, Kupcinskas J, Link A, Mulder CJ, Goldenberg SD, Arasaradnam R, Sokol H, Gasbarrini A, Hoegenauer C, Terveer EM, Kuijper EJ, Arkkila P. Keller JJ, et al. Among authors: goldenberg sd. United European Gastroenterol J. 2020 Apr;8(3):353-354. doi: 10.1177/2050640620910847. Epub 2020 Mar 13. United European Gastroenterol J. 2020. PMID: 32213039 Free PMC article. No abstract available.
Extended-pulsed fidaxomicin versus vancomycin for Clostridium difficile infection in patients 60 years and older (EXTEND): a randomised, controlled, open-label, phase 3b/4 trial.
Guery B, Menichetti F, Anttila VJ, Adomakoh N, Aguado JM, Bisnauthsing K, Georgopali A, Goldenberg SD, Karas A, Kazeem G, Longshaw C, Palacios-Fabrega JA, Cornely OA, Vehreschild MJGT; EXTEND Clinical Study Group. Guery B, et al. Among authors: goldenberg sd. Lancet Infect Dis. 2018 Mar;18(3):296-307. doi: 10.1016/S1473-3099(17)30751-X. Epub 2017 Dec 19. Lancet Infect Dis. 2018. PMID: 29273269 Clinical Trial.
Fidaxomicin for the treatment of Clostridium difficile infection (CDI) in at-risk patients with inflammatory bowel disease, fulminant CDI, renal impairment or hepatic impairment: a retrospective study of routine clinical use (ANEMONE).
Vehreschild MJGT, Taori S, Goldenberg SD, Thalhammer F, Bouza E, van Oene J, Wetherill G, Georgopali A. Vehreschild MJGT, et al. Among authors: goldenberg sd. Eur J Clin Microbiol Infect Dis. 2018 Nov;37(11):2097-2106. doi: 10.1007/s10096-018-3344-1. Epub 2018 Aug 11. Eur J Clin Microbiol Infect Dis. 2018. PMID: 30099637 Free PMC article.
Correction to: Fidaxomicin for the treatment of Clostridium difficile infection (CDI) in at-risk patients with inflammatory bowel disease, fulminant CDI, renal impairment or hepatic impairment: a retrospective study of routine clinical use (ANEMONE).
Vehreschild MJGT, Taori S, Goldenberg SD, Thalhammer F, Bouza E, van Oene J, Wetherill G, Georgopali A. Vehreschild MJGT, et al. Among authors: goldenberg sd. Eur J Clin Microbiol Infect Dis. 2019 Jan;38(1):199. doi: 10.1007/s10096-018-3410-8. Eur J Clin Microbiol Infect Dis. 2019. PMID: 30406879 Free PMC article.
Stool for fecal microbiota transplantation should be classified as a transplant product and not as a drug.
Keller JJ, Vehreschild MJ, Hvas CL, Jørgensen SM, Kupciskas J, Link A, Mulder CJ, Goldenberg SD, Arasaradnam R, Sokol H, Gasbarrini A, Hoegenauer C, Terveer EM, Kuijper EJ, Arkkila P; UEG working group of the Standards and Guidelines initiative Stool banking for FMT. Keller JJ, et al. Among authors: goldenberg sd. United European Gastroenterol J. 2019 Dec;7(10):1408-1410. doi: 10.1177/2050640619887579. Epub 2019 Nov 14. United European Gastroenterol J. 2019. PMID: 31839966 Free PMC article. No abstract available.
A standardised model for stool banking for faecal microbiota transplantation: a consensus report from a multidisciplinary UEG working group.
Keller JJ, Ooijevaar RE, Hvas CL, Terveer EM, Lieberknecht SC, Högenauer C, Arkkila P, Sokol H, Gridnyev O, Mégraud F, Kump PK, Nakov R, Goldenberg SD, Satokari R, Tkatch S, Sanguinetti M, Cammarota G, Dorofeev A, Gubska O, Ianiro G, Mattila E, Arasaradnam RP, Sarin SK, Sood A, Putignani L, Alric L, Baunwall SMD, Kupcinskas J, Link A, Goorhuis AG, Verspaget HW, Ponsioen C, Hold GL, Tilg H, Kassam Z, Kuijper EJ, Gasbarrini A, Mulder CJJ, Williams HRT, Vehreschild MJGT. Keller JJ, et al. Among authors: goldenberg sd. United European Gastroenterol J. 2021 Mar;9(2):229-247. doi: 10.1177/2050640620967898. Epub 2021 Mar 9. United European Gastroenterol J. 2021. PMID: 33151137 Free PMC article.
100 results