PMID- 27547925
OWN - NLM
STAT- MEDLINE
DCOM- 20170512
LR  - 20220409
IS  - 1539-3704 (Electronic)
IS  - 0003-4819 (Print)
IS  - 0003-4819 (Linking)
VI  - 165
IP  - 9
DP  - 2016 Nov 1
TI  - Effect of Fecal Microbiota Transplantation on Recurrence in Multiply Recurrent 
      Clostridium difficile Infection: A Randomized Trial.
PG  - 609-616
LID - 10.7326/M16-0271 [doi]
AB  - BACKGROUND: To date, evidence for the efficacy of fecal microbiota 
      transplantation (FMT) in recurrent Clostridium difficile infection (CDI) has been 
      limited to case series and open-label clinical trials. OBJECTIVE: To determine 
      the efficacy and safety of FMT for treatment of recurrent CDI. DESIGN: 
      Randomized, controlled, double-blind clinical trial. (ClinicalTrials.gov: 
      NCT01703494). SETTING: Two academic medical centers. PATIENTS: 46 patients who 
      had 3 or more recurrences of CDI and received a full course of vancomycin for 
      their most recent acute episode. INTERVENTION: Fecal microbiota transplantation 
      with donor stool (heterologous) or patient's own stool (autologous) administered 
      by colonoscopy. MEASUREMENTS: The primary end point was resolution of diarrhea 
      without the need for further anti-CDI therapy during the 8-week follow-up. Safety 
      data were compared between treatment groups via review of adverse events (AEs), 
      serious AEs (SAEs), and new medical conditions for 6 months after FMT. Fecal 
      microbiota analyses were performed on patients' stool before and after FMT and 
      also on donors' stool. RESULTS: In the intention-to-treat analysis, 20 of 22 
      patients (90.9%) in the donor FMT group achieved clinical cure compared with 15 
      of 24 (62.5%) in the autologous FMT group (P = 0.042). Resolution after 
      autologous FMT differed by site (9 of 10 vs. 6 of 14 [P = 0.033]). All 9 patients 
      who developed recurrent CDI after autologous FMT were free of further CDI after 
      subsequent donor FMT. There were no SAEs related to FMT. Donor FMT restored gut 
      bacterial community diversity and composition to resemble that of healthy donors. 
      LIMITATION: The study included only patients who had 3 or more recurrences and 
      excluded those who were immunocompromised and aged 75 years or older. CONCLUSION: 
      Donor stool administered via colonoscopy seemed safe and was more efficacious 
      than autologous FMT in preventing further CDI episodes. PRIMARY FUNDING SOURCE: 
      National Institute of Diabetes and Digestive and Kidney Diseases.
FAU - Kelly, Colleen R
AU  - Kelly CR
AD  - From Warren Alpert Medical School of Brown University, Miriam Hospital, and 
      Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, 
      Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein 
      College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, 
      Rhode Island.
FAU - Khoruts, Alexander
AU  - Khoruts A
AD  - From Warren Alpert Medical School of Brown University, Miriam Hospital, and 
      Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, 
      Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein 
      College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, 
      Rhode Island.
FAU - Staley, Christopher
AU  - Staley C
AD  - From Warren Alpert Medical School of Brown University, Miriam Hospital, and 
      Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, 
      Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein 
      College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, 
      Rhode Island.
FAU - Sadowsky, Michael J
AU  - Sadowsky MJ
AD  - From Warren Alpert Medical School of Brown University, Miriam Hospital, and 
      Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, 
      Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein 
      College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, 
      Rhode Island.
FAU - Abd, Mortadha
AU  - Abd M
AD  - From Warren Alpert Medical School of Brown University, Miriam Hospital, and 
      Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, 
      Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein 
      College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, 
      Rhode Island.
FAU - Alani, Mustafa
AU  - Alani M
AD  - From Warren Alpert Medical School of Brown University, Miriam Hospital, and 
      Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, 
      Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein 
      College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, 
      Rhode Island.
FAU - Bakow, Brianna
AU  - Bakow B
AD  - From Warren Alpert Medical School of Brown University, Miriam Hospital, and 
      Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, 
      Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein 
      College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, 
      Rhode Island.
FAU - Curran, Patrizia
AU  - Curran P
AD  - From Warren Alpert Medical School of Brown University, Miriam Hospital, and 
      Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, 
      Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein 
      College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, 
      Rhode Island.
FAU - McKenney, Joyce
AU  - McKenney J
AD  - From Warren Alpert Medical School of Brown University, Miriam Hospital, and 
      Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, 
      Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein 
      College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, 
      Rhode Island.
FAU - Tisch, Allison
AU  - Tisch A
AD  - From Warren Alpert Medical School of Brown University, Miriam Hospital, and 
      Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, 
      Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein 
      College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, 
      Rhode Island.
FAU - Reinert, Steven E
AU  - Reinert SE
AD  - From Warren Alpert Medical School of Brown University, Miriam Hospital, and 
      Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, 
      Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein 
      College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, 
      Rhode Island.
FAU - Machan, Jason T
AU  - Machan JT
AD  - From Warren Alpert Medical School of Brown University, Miriam Hospital, and 
      Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, 
      Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein 
      College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, 
      Rhode Island.
FAU - Brandt, Lawrence J
AU  - Brandt LJ
AD  - From Warren Alpert Medical School of Brown University, Miriam Hospital, and 
      Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, 
      Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein 
      College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, 
      Rhode Island.
LA  - eng
SI  - ClinicalTrials.gov/NCT01703494
GR  - R21 AI114722/AI/NIAID NIH HHS/United States
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20160823
PL  - United States
TA  - Ann Intern Med
JT  - Annals of internal medicine
JID - 0372351
SB  - IM
CIN - Clin Orthop Relat Res. 2016 Aug;474(8):1855-6. PMID: 27154531
CIN - Ann Intern Med. 2016 Nov 1;165(9):667-668. PMID: 27548329
CIN - BMJ. 2016 Aug 23;354:i4638. PMID: 27558248
MH  - *Clostridioides difficile
MH  - Clostridium Infections/microbiology/*therapy
MH  - Colonoscopy
MH  - Diarrhea/microbiology/*therapy
MH  - Double-Blind Method
MH  - *Fecal Microbiota Transplantation/adverse effects/methods
MH  - Female
MH  - Humans
MH  - Intention to Treat Analysis
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Recurrence
MH  - Treatment Outcome
PMC - PMC5909820
MID - NIHMS958183
EDAT- 2016/11/01 06:00
MHDA- 2017/05/13 06:00
PMCR- 2018/04/20
CRDT- 2016/08/23 06:00
PHST- 2016/11/01 06:00 [pubmed]
PHST- 2017/05/13 06:00 [medline]
PHST- 2016/08/23 06:00 [entrez]
PHST- 2018/04/20 00:00 [pmc-release]
AID - 2545886 [pii]
AID - 10.7326/M16-0271 [doi]
PST - ppublish
SO  - Ann Intern Med. 2016 Nov 1;165(9):609-616. doi: 10.7326/M16-0271. Epub 2016 Aug 
      23.