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

Clinical Gastroenterology and Hepatology

Volumn 12, Issue 2, 2014, Pages 289-291

  Hecht, Gail A ^a   Blaser, Martin J ^b   Gordon, Jeffrey ^c   Kaplan, Lee M ^d   Knight, Rob ^e   Laine, Loren ^f,g   Peek, Richard ^h   Sanders, Mary Ellen ⁱ   Sartor, Balfour ^j   Wu, Gary D ^k   Yang, Vincent W ^l  

^a LOYOLA UNIVERSITY CHICAGO   (United States)

^b NEW YORK UNIVERSITY MEDICAL CENTER   (United States)

^c WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d MASSACHUSETTS GENERAL HOSPITAL   (United States)

^e UNIVERSITY OF COLORADO   (United States)

^f YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^g VA CONNECTICUT HEALTHCARE SYSTEM   (United States)

^h VANDERBILT UNIVERSITY   (United States)

ⁱ International Scientific Association for Probiotics and Prebiotics   (United States)

^j UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^k UNIVERSITY OF PENNSYLVANIA   (United States)

^l STONY BROOK UNIVERSITY   (United States)

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Author keywords

[No Author keywords available]

Indexed keywords

CLOSTRIDIUM DIFFICILE INFECTION; DRUG APPROVAL; EDITORIAL; FECES MICROFLORA; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; HUMAN; NONHUMAN; PHENOTYPE;

BIOLOGICAL THERAPY; FECES; HUMANS; INVESTIGATIONAL NEW DRUG APPLICATION; MICROBIOTA;

EID: 84892484552     PISSN: 15423565     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cgh.2013.10.009     Document Type: Editorial

References (16)

1. Faith J.J., Guruge J.L., Charbonneau M., et al. The long-term stability of the human gut microbiota. Science 2013, 341:1237439.
2. Holmes E., Li J.V., Marchesi J.R., et al. Gut microbiota composition and activity in relation to host metabolic phenotype and disease risk. Cell Metab 2012, 16:559-564.
3. Sommer F., Bäckhed F. The gut microbiota: masters of host development and physiology. Nat Rev Microbiol 2013, 11:227-238.
4. Frank D.N., St Amand A.L., Feldman R.A., et al. Molecular-phylogenetic characterization of microbial community imbalances in human inflammatory bowel diseases. Proc Natl Acad Sci U S A 2007, 104:13780-13785.
5. Henao-Mejia J., Elinav E., Jin C., et al. Inflammasome-mediated dysbiosis regulates progression of NAFLD and obesity. Nature 2012, 482:179-185.
6. Karlsson F.H., Tremaroli V., Nookaew I., et al. Gut metagenome in European women with normal, impaired and diabetic glucose control. Nature 2013, 498:99-103.
7. Cox L.M., Blaser M.J. Pathways in microbe-induced obesity. Cell Metab 2013, 17:883-894.
8. Ridaura V.K., Faith J.J., Rey F.E., et al. Gut microbiota from twins discordant for obesity modulate metabolism in mice. Science 2013, 341:1241214.
9. Wu G.D., Lewis J.D. Analysis of the human gut microbiome and association with disease. Clin Gastroenterol Hepatol 2013, 11:774-777.
10. van Nood E., Vrieze A., Nieuwdorp M., et al. Duodenal infusion of donor feces for recurrent Clostridium difficile. NEngl J Med 2013, 368:407-415.
11. Dupont H.L. Diagnosis and management of Clostridium difficile infection. Clin Gastroenterol Hepatol 2013, 11:1216-1223.
12. Vrieze A., Van Nood E., Holleman F., et al. Transfer of intestinal microbiota from lean donors increases insulin sensitivity in individuals with metabolic syndrome. Gastroenterology 2012, 143:913-916.
13. Borody T.J., Warren E.F., Leis S., et al. Treatment of ulcerative colitis using fecal bacteriotherapy. JClin Gastroenterol 2003, 37:42-47.
14. Virgin H.W., Todd J.A. Metagenomics and personalized medicine. Cell 2011, 147:44-56.
15. Gordon J.I. Honor thy gut symbionts redux. Science 2012, 336:1251-1253.
16. Kelly C.R., Kunde S.S., Khoruts A. Guidance on preparing an investigational new drug application for fecal microbiota transplantation studies. Clin Gastroenterol Hepatol 2014, 12:283-288.