What is the value of a food and drug administration investigational new drug application for fecal microbiota transplantation to treat Clostridium difficile Infection?

Affiliations

¹ Division of Gastroenterology and Nutrition, Department of Medicine, Loyola University Chicago-Stritch School of Medicine, Chicago, Illinois.
² Departments of Medicine and Microbiology, Department of Veterans Affairs Medical Center, New York University Langone Medical Center, New York, New York.
³ Center for Genome Sciences and Systems Biology, Washington University School of Medicine, St Louis, Missouri.
⁴ Obesity, Metabolism and Nutrition Institute, Gastrointestinal Unit, Massachusetts General Hospital, Boston, Massachusetts.
⁵ Howard Hughes Medical Institute, Departments of Chemistry and Biochemistry and Computer Science, BioFrontiers Institute, University of Colorado at Boulder, Boulder, Colorado.
⁶ Section of Digestive Diseases, Yale University School of Medicine, New Haven, Connecticut; VA Connecticut Healthcare System, West Haven, Connecticut.
⁷ Division of Gastroenterology, Vanderbilt University, Nashville, Tennessee.
⁸ International Scientific Association for Probiotics and Prebiotics, Davis, California.
⁹ Departments of Medicine, Microbiology and Immunology, Division of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.
¹⁰ Division of Gastroenterology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
¹¹ Department of Medicine, Stony Brook University School of Medicine, Stony Brook, New York.

Editorial

Gail A Hecht et al. Clin Gastroenterol Hepatol. 2014 Feb.

. 2014 Feb;12(2):289-91.

doi: 10.1016/j.cgh.2013.10.009. Epub 2013 Oct 20.

¹ Division of Gastroenterology and Nutrition, Department of Medicine, Loyola University Chicago-Stritch School of Medicine, Chicago, Illinois.
² Departments of Medicine and Microbiology, Department of Veterans Affairs Medical Center, New York University Langone Medical Center, New York, New York.
³ Center for Genome Sciences and Systems Biology, Washington University School of Medicine, St Louis, Missouri.
⁴ Obesity, Metabolism and Nutrition Institute, Gastrointestinal Unit, Massachusetts General Hospital, Boston, Massachusetts.
⁵ Howard Hughes Medical Institute, Departments of Chemistry and Biochemistry and Computer Science, BioFrontiers Institute, University of Colorado at Boulder, Boulder, Colorado.
⁶ Section of Digestive Diseases, Yale University School of Medicine, New Haven, Connecticut; VA Connecticut Healthcare System, West Haven, Connecticut.
⁷ Division of Gastroenterology, Vanderbilt University, Nashville, Tennessee.
⁸ International Scientific Association for Probiotics and Prebiotics, Davis, California.
⁹ Departments of Medicine, Microbiology and Immunology, Division of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.
¹⁰ Division of Gastroenterology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
¹¹ Department of Medicine, Stony Brook University School of Medicine, Stony Brook, New York.

No abstract available

Comment on

Guidance on preparing an investigational new drug application for fecal microbiota transplantation studies.
Kelly CR, Kunde SS, Khoruts A. Kelly CR, et al. Clin Gastroenterol Hepatol. 2014 Feb;12(2):283-8. doi: 10.1016/j.cgh.2013.09.060. Epub 2013 Oct 6. Clin Gastroenterol Hepatol. 2014. PMID: 24107393 Free PMC article.