Multidonor intensive faecal microbiota transplantation for active ulcerative colitis: a randomised placebo-controlled trial

The Lancet

Volumn 389, Issue 10075, 2017, Pages 1218-1228

  Paramsothy, Sudarshan ^a,d,e,f   Kamm, Michael A ^c   Kaakoush, Nadeem O ^a   Walsh, Alissa J ^d   van den Bogaerde, Johan ^e   Samuel, Douglas ^f   Leong, Rupert W L ^f   Connor, Susan ^b,g,h   Ng, Watson ^b,g   Paramsothy, Ramesh ^g   Xuan, Wei ^b,h   Lin, Enmoore ⁱ   Mitchell, Hazel M ^a   Borody, Thomas J ⁱ  

^a UNIVERSITY OF NEW SOUTH WALES   (Australia)

^b UNIVERSITY OF NEW SOUTH WALES   (Australia)

^c ST VINCENT S HOSPITAL   (Australia)

^d ST VINCENT S HOSPITAL   (Australia)

^e NAMBOUR GENERAL HOSPITAL   (Australia)

^f BANKSTOWN LIDCOMBE HOSPITAL   (Australia)

^g LIVERPOOL HOSPITAL   (Australia)

^h INGHAM INSTITUTE   (Australia)

ⁱ Centre for Digestive Diseases   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; ALANINE AMINOTRANSFERASE; ALLOPURINOL; ASPARTATE AMINOTRANSFERASE; AZATHIOPRINE; BACTERIAL DNA; BIOLOGICAL PRODUCT; BUDESONIDE; COMPLEMENTARY DNA; CORTICOSTEROID; ENEMA; IMMUNOMODULATING AGENT; MERCAPTOPURINE; MESALAZINE; METHOTREXATE; PLACEBO; PREDNISONE; PROBIOTIC AGENT; RNA 16S; SODIUM CHLORIDE; TUMOR NECROSIS FACTOR INHIBITOR;

ABDOMINAL PAIN; ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ANUS FISSURE; ANXIETY DISORDER; ARTHRALGIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BACKACHE; BACTERIUM; BACTEROIDES FRAGILIS; BARNESIELLA; BIFIDOBACTERIUM LONGUM; BIOLOGICAL THERAPY; BLAUTIA; BLOATING; BLURRED VISION; CHILL; CLINICAL EFFECTIVENESS; CLINICAL OUTCOME; CLOSTRIDIUM; CLOSTRIDIUM PERFRINGENS; COLITIS; COLON LAVAGE; COLONOSCOPY; CONTROLLED STUDY; CORTICOSTEROID THERAPY; COUGHING; DEPRESSION; DIARRHEA; DIGESTIVE SYSTEM DISEASE ASSESSMENT; DIZZINESS; DOREA; DOUBLE BLIND PROCEDURE; DRUG DOSE REDUCTION; DRUG TREATMENT FAILURE; DRY SKIN; ELECTIVE SURGERY; ENTEROCOLITIS; ESCHERICHIA; ESCHERICHIA COLI; ESCHERICHIA FAECALIS; FATIGUE; FECAL MICROBIOTA TRANSPLANTATION; FECES ANALYSIS; FECES INCONTINENCE; FECES MICROFLORA; FEMALE; FEVER; FLATULENCE; FLU LIKE SYNDROME; FOOT FRACTURE; FUSOBACTERIUM; GASTROESOPHAGEAL REFLUX; GASTROINTESTINAL SYMPTOM; GENITAL HERPES; HEADACHE; HEART PALPITATION; HEMORRHOID; HUMAN; INFECTION COMPLICATION; INSOMNIA; INTENTION TO TREAT ANALYSIS; IRRITABILITY; LACTOBACILLUS CASEI; LIP DISEASE; LIP INFECTION; LUNG INFECTION; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; MAYO SCORE; MICROBIAL DIVERSITY; MOUTH INFECTION; MULTICENTER STUDY; MYALGIA; NAUSEA; NONHUMAN; OPEN STUDY; OTITIS MEDIA; PARABACTEROIDES; PATIENT SAFETY; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RASH; REMISSION; RUMINOCOCCUS; SINUSITIS; SOFT TISSUE INFECTION; SORE THROAT; SUTTERELLA; TREATMENT RESPONSE; ULCERATIVE COLITIS; UNRELATED DONORS; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INJURY; URTICARIA; VOMITING; CLINICAL TRIAL; DONOR; FECES; INTESTINE FLORA; MICROBIOLOGY; MIDDLE AGED; PROCEDURES; SEVERITY OF ILLNESS INDEX;

ADULT; COLITIS, ULCERATIVE; COLONOSCOPY; DOUBLE-BLIND METHOD; FECAL MICROBIOTA TRANSPLANTATION; FECES; FEMALE; GASTROINTESTINAL MICROBIOME; HUMANS; MALE; MIDDLE AGED; REMISSION INDUCTION; SEVERITY OF ILLNESS INDEX; TISSUE DONORS;

EID: 85012869662     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(17)30182-4     Document Type: Article

References (29)

1. 1 Kostic, AD, Xavier, RJ, Gevers, D, The microbiome in inflammatory bowel disease: current status and the future ahead. Gastroenterology 146 (2014), 1489–1499.
2. 2 Shanahan, F, Quigley, EM, Manipulation of the microbiota for treatment of IBS and IBD: challenges and controversies. Gastroenterology 146 (2014), 1554–1563.
3. 3 Borody, TJ, Brandt, LJ, Paramsothy, S, Therapeutic faecal microbiota transplantation: current status and future developments. Curr Opin Gastroenterol 30 (2014), 97–105.
4. 4 van Nood, E, Vrieze, A, Nieuwdorp, M, et al. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med 368 (2013), 407–415.
5. 5 Moayyedi, P, Surette, MG, Kim, PT, et al. Fecal microbiota transplantation induces remission in patients with active ulcerative colitis in a randomized controlled trial. Gastroenterology 149 (2015), 102–109 e6.
6. 6 Rossen, NG, Fuentes, S, van der Spek, MJ, et al. Findings from a randomized controlled trial of fecal transplantation for patients with ulcerative colitis. Gastroenterology 149 (2015), 110–118 e4.
7. 7 Schroeder, KW, Tremaine, WJ, Ilstrup, DM, Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis: a randomized study. N Engl J Med 317 (1987), 1625–1629.
8. 8 Paramsothy, S, Borody, TJ, Lin, E, et al. Donor recruitment for fecal microbiota transplantation. Inflamm Bowel Dis 21 (2015), 1600–1606.
9. 9 Travis, SP, Schnell, D, Krzeski, P, et al. Developing an instrument to assess the endoscopic severity of ulcerative colitis: the Ulcerative Colitis Endoscopic Index of Severity (UCEIS). Gut 61 (2012), 535–542.
10. 10 Guyatt, G, Mitchell, A, Irvine, EJ, et al. A new measure of health status for clinical trials in inflammatory bowel disease. Gastroenterology 96 (1989), 804–810.
11. 11 Schloss, PD, Westcott, SL, Ryabin, T, et al. Introducing mothur: open-source, platform-independent, community-supported software for describing and comparing microbial communities. Appl Environ Microbiol 75 (2009), 7537–7541.
12. 12 Yilmaz, P, Parfrey, LW, Yarza, P, et al. The SILVA and “All-species Living Tree Project (LTP)” taxonomic frameworks. Nucleic Acids Res 42 (2014), D643–D648.
13. 13 Edgar, RC, Haas, BJ, Clemente, JC, Quince, C, Knight, R, UCHIME improves sensitivity and speed of chimera detection. Bioinformatics 27 (2011), 2194–2200.
14. 14 Cole, JR, Wang, Q, Fish, JA, et al. Ribosomal Database Project: data and tools for high throughput rRNA analysis. Nucleic Acids Res 42 (2014), D633–D642.
15. 15 Anderson, JL, Edney, RJ, Whelan, K, Systematic review: faecal microbiota transplantation in the management of inflammatory bowel disease. Aliment Pharmacol Ther 36 (2012), 503–516.
16. 16 Segata, N, Izard, J, Waldron, L, et al. Metagenomic biomarker discovery and explanation. Genome Biol, 12, 2011, R60.
17. 17 Goecks, J, Nekrutenko, A, Taylor, J, et al. Galaxy: a comprehensive approach for supporting accessible, reproducible, and transparent computational research in the life sciences. Genome Biol, 11, 2010, R86.
18. 18 Lee, CH, Steiner, T, Petrof, EO, et al. Frozen vs fresh fecal microbiota transplantation and clinical resolution of diarrhea in patients with recurrent Clostridium difficile infection: a randomized clinical trial. JAMA 315 (2016), 142–149.
19. 19 Hamilton, MJ, Weingarden, AR, Unno, T, et al. High-throughput DNA sequence analysis reveals stable engraftment of gut microbiota following transplantation of previously frozen fecal bacteria. Gut Microbes 4 (2013), 125–135.
20. 20 Kump, PK, Grochenig, HP, Spindelbock, W, et al. Preliminary clinical results of repeatedly fecal microbiota transplantation (FMT) in chronic active ulcerative colitis. United European Gastroenterol J, 1(suppl 1), 2013, A57.
21. 21 Kump, PK, Grochenig, HP, Lackner, S, et al. Alteration of intestinal dysbiosis by fecal microbiota transplantation does not induce remission in patients with chronic active ulcerative colitis. Inflamm Bowel Dis 19 (2013), 2155–2165.
22. 22 Angelberger, S, Reinisch, W, Makristathis, A, et al. Temporal bacterial community dynamics vary among ulcerative colitis patients after fecal microbiota transplantation. Am J Gastroenterol 108 (2013), 1620–1630.
23. 23 Sartor, RB, Genetics and environmental interactions shape the intestinal microbiome to promote inflammatory bowel disease versus mucosal homeostasis. Gastroenterology 139 (2010), 1816–1819.
24. 24 Vermeire, S, Joossens, M, Verbeke, K, et al. Donor species richness determines faecal microbiota transplantation success in inflammatory bowel disease. J Crohns Colitis 10 (2016), 387–394.
25. 25 Li, SS, Zhu, A, Benes, V, et al. Durable coexistence of donor and recipient strains after fecal microbiota transplantation. Science 352 (2016), 586–589.
26. 26 Alang, N, Kelly, CR, Weight gain after fecal microbiota transplantation. Open Forum Infect Dis, 2, 2015, ofv004.
27. 27 Ohkusa, T, Okayasu, I, Ogihara, T, et al. Induction of experimental ulcerative colitis by Fusobacterium varium isolated from colonic mucosa of patients with ulcerative colitis. Gut 52 (2003), 79–83.
28. 28 Strauss, J, Kaplan, GG, Beck, PL, et al. Invasive potential of gut mucosa-derived Fusobacterium nucleatum positively correlates with IBD status of the host. Inflamm Bowel Dis 17 (2011), 1971–1978.
29. 29 Youngster, I, Russell, GH, Pindar, C, et al. Oral, capsulized, frozen fecal microbiota transplantation for relapsing Clostridium difficile infection. JAMA 312 (2014), 1772–1778.