Literature DB >> 29039256

Ethical Considerations in Microbial Therapeutic Clinical Trials.

Michael H Woodworth1, Kaitlin L Sitchenko1, Cynthia Carpentieri1, Rachel J Friedman-Moraco1, Tiffany Wang2, Colleen S Kraft1,3.   

Abstract

As understanding of the human microbiome improves, novel therapeutic targets to improve human health with microbial therapeutics will continue to expand. We outline key considerations of balancing risks and benefits, optimising access, returning key results to research participants, and potential conflicts of interest.

Entities:  

Keywords:  Clostridium difficile; FMT; ethics; fecal microbiota transplant; microbiome; recurrent Clostridium difficile

Mesh:

Year:  2017        PMID: 29039256      PMCID: PMC5996990          DOI: 10.1080/20502877.2017.1387386

Source DB:  PubMed          Journal:  New Bioeth        ISSN: 2050-2877


  19 in total

1.  Ethical, legal, and social considerations in conducting the Human Microbiome Project.

Authors:  Amy L McGuire; James Colgrove; Simon N Whitney; Christina M Diaz; Daniel Bustillos; James Versalovic
Journal:  Genome Res       Date:  2008-10-29       Impact factor: 9.043

2.  Ensuring the safe and effective FDA regulation of fecal microbiota transplantation.

Authors:  Rachel E Sachs; Carolyn A Edelstein
Journal:  J Law Biosci       Date:  2015-07-06

3.  Economic evaluation of fecal microbiota transplantation for the treatment of recurrent Clostridium difficile infection in Australia.

Authors:  Gregory Merlo; Nicholas Graves; David Brain; Luke B Connelly
Journal:  J Gastroenterol Hepatol       Date:  2016-12       Impact factor: 4.029

Review 4.  Challenges in fecal donor selection and screening for fecal microbiota transplantation: A review.

Authors:  Michael H Woodworth; Cynthia Carpentieri; Kaitlin L Sitchenko; Colleen S Kraft
Journal:  Gut Microbes       Date:  2017-01-27

5.  Duodenal infusion of donor feces for recurrent Clostridium difficile.

Authors:  Els van Nood; Anne Vrieze; Max Nieuwdorp; Susana Fuentes; Erwin G Zoetendal; Willem M de Vos; Caroline E Visser; Ed J Kuijper; Joep F W M Bartelsman; Jan G P Tijssen; Peter Speelman; Marcel G W Dijkgraaf; Josbert J Keller
Journal:  N Engl J Med       Date:  2013-01-16       Impact factor: 91.245

6.  Efficacy and effectiveness of an rVSV-vectored vaccine expressing Ebola surface glycoprotein: interim results from the Guinea ring vaccination cluster-randomised trial.

Authors:  Ana Maria Henao-Restrepo; Ira M Longini; Matthias Egger; Natalie E Dean; W John Edmunds; Anton Camacho; Miles W Carroll; Moussa Doumbia; Bertrand Draguez; Sophie Duraffour; Godwin Enwere; Rebecca Grais; Stephan Gunther; Stefanie Hossmann; Mandy Kader Kondé; Souleymane Kone; Eeva Kuisma; Myron M Levine; Sema Mandal; Gunnstein Norheim; Ximena Riveros; Aboubacar Soumah; Sven Trelle; Andrea S Vicari; Conall H Watson; Sakoba Kéïta; Marie Paule Kieny; John-Arne Røttingen
Journal:  Lancet       Date:  2015-08-03       Impact factor: 79.321

7.  Addressing Benefits, Risks and Consent in Next Generation Sequencing Studies.

Authors:  R Meller
Journal:  J Clin Res Bioeth       Date:  2015-12-14

8.  Peripheral Neuropathy After Fecal Microbiota Transplantation for Clostridium difficile Infection: A Case Report.

Authors:  Michelle M Didesch; Allison Averill; Mooyeon Oh-Park
Journal:  PM R       Date:  2016-01-27       Impact factor: 2.298

9.  Effect of Fecal Microbiota Transplantation on Recurrence in Multiply Recurrent Clostridium difficile Infection: A Randomized Trial.

Authors:  Colleen R Kelly; Alexander Khoruts; Christopher Staley; Michael J Sadowsky; Mortadha Abd; Mustafa Alani; Brianna Bakow; Patrizia Curran; Joyce McKenney; Allison Tisch; Steven E Reinert; Jason T Machan; Lawrence J Brandt
Journal:  Ann Intern Med       Date:  2016-08-23       Impact factor: 25.391

Review 10.  Systematic Review: Adverse Events of Fecal Microbiota Transplantation.

Authors:  Sinan Wang; Mengque Xu; Weiqiang Wang; Xiaocang Cao; Meiyu Piao; Samiullah Khan; Fang Yan; Hailong Cao; Bangmao Wang
Journal:  PLoS One       Date:  2016-08-16       Impact factor: 3.240

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  2 in total

1.  Medical students' perception on fecal microbiota transplantation.

Authors:  Petru C Madar; Oana Petre; Adriana Baban; Dan L Dumitrascu
Journal:  BMC Med Educ       Date:  2019-10-11       Impact factor: 2.463

2.  Introducing the microbiome: Interdisciplinary perspectives.

Authors:  Davina Höll; Leonie N Bossert
Journal:  Endeavour       Date:  2022-06-03       Impact factor: 0.600

  2 in total

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