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PMID- 29261736
OWN - NLM
STAT- MEDLINE
DCOM- 20180108
LR  - 20180108
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 12
IP  - 12
DP  - 2017
TI  - Randomized clinical trial to evaluate the effect of fecal microbiota transplant
      for initial Clostridium difficile infection in intestinal microbiome.
PG  - e0189768
LID - 10.1371/journal.pone.0189768 [doi]
AB  - OBJECTIVE: The aim of this study was to evaluate the impact of fecal
      donor-unrelated donor mix (FMT-FURM) transplantation as first-line therapy for C.
      difficile infection (CDI) in intestinal microbiome. METHODS: We designed an open,
      two-arm pilot study with oral vancomycin (250mg every 6 h for 10-14 days) or
      FMT-FURM as treatments for the first CDI episode in hospitalized adult patients
      in Hospital Universitario "Dr. Jose Eleuterio Gonzalez". Patients were randomized
      by a closed envelope method in a 1: 1 ratio to either oral vancomycin or
      FMT-FURM. CDI resolution was considered when there was a reduction on the Bristol
      scale of at least 2 points, a reduction of at least 50% in the number of bowel
      movements, absence of fever, and resolution of abdominal pain (at least two
      criteria). From each patient, a fecal sample was obtained at days 0, 3, and 7
      after treatment. Specimens were cultured to isolate C. difficile, and isolates
      were characterized by PCR. Susceptibility testing of isolates was performed using
      the agar dilution method. Fecal samples and FMT-FURM were analyzed by 16S rRNA
      sequencing. RESULTS: We included 19 patients; 10 in the vancomycin arm and 9 in
      the FMT-FURM arm. However, one of the patients in the vancomycin arm and two
      patients in the FMT-FURM arm were eliminated. Symptoms resolved in 8/9 patients
      (88.9%) in the vancomycin group, while symptoms resolved in 4/7 patients (57.1%) 
      after the first FMT-FURM dose (P = 0.26) and in 5/7 patients (71.4%) after the
      second dose (P = 0.55). During the study, no adverse effects attributable to
      FMT-FURM were observed in patients. Twelve isolates were recovered, most isolates
      carried tcdB, tcdA, cdtA, and cdtB, with an 18-bp deletion in tcdC. All isolates 
      were resistant to ciprofloxacin and moxifloxacin but susceptible to
      metronidazole, linezolid, fidaxomicin, and tetracycline. In the FMT-FURM group,
      the bacterial composition was dominated by Firmicutes, Bacteroidetes, and
      Proteobacteria at all-time points and the microbiota were remarkably stable over 
      time. The vancomycin group showed a very different pattern of the microbial
      composition when comparing to the FMT-FURM group over time. CONCLUSION: The
      results of this preliminary study showed that FMT-FURM for initial CDI is
      associated with specific bacterial communities that do not resemble the donors'
      sample.
FAU - Camacho-Ortiz, Adrian
AU  - Camacho-Ortiz A
AD  - Coordinacion de Epidemiologia Hospitalaria, Hospital Universitario "Dr. Jose
      Eleuterio Gonzalez", Universidad Autonoma de Nuevo Leon, Monterrey, Nuevo Leon,
      Mexico.
AD  - Servicio de Infectologia, Hospital Universitario "Dr. Jose Eleuterio Gonzalez",
      Universidad Autonoma de Nuevo Leon, Monterrey, Nuevo Leon, Mexico.
FAU - Gutierrez-Delgado, Eva Maria
AU  - Gutierrez-Delgado EM
AD  - Servicio de Infectologia, Hospital Universitario "Dr. Jose Eleuterio Gonzalez",
      Universidad Autonoma de Nuevo Leon, Monterrey, Nuevo Leon, Mexico.
FAU - Garcia-Mazcorro, Jose F
AU  - Garcia-Mazcorro JF
AD  - Laboratorio de Fisiologia Digestiva y Motilidad Gastrointestinal, Instituto de
      Investigaciones Medico-Biologicas, Universidad Veracruzana, Veracruz, Mexico.
FAU - Mendoza-Olazaran, Soraya
AU  - Mendoza-Olazaran S
AD  - Servicio de Gastroenterologia, Hospital Universitario "Dr. Jose Eleuterio
      Gonzalez", Universidad Autonoma de Nuevo Leon, Monterrey, Nuevo Leon, Mexico.
FAU - Martinez-Melendez, Adrian
AU  - Martinez-Melendez A
AD  - Departamento de Microbiologia e Inmunologia, Facultad de Ciencias Biologicas,
      Universidad Autonoma de Nuevo Leon, San Nicolas de los Garza, Nuevo Leon, Mexico.
FAU - Palau-Davila, Laura
AU  - Palau-Davila L
AD  - Coordinacion de Epidemiologia Hospitalaria, Hospital Universitario "Dr. Jose
      Eleuterio Gonzalez", Universidad Autonoma de Nuevo Leon, Monterrey, Nuevo Leon,
      Mexico.
FAU - Baines, Simon D
AU  - Baines SD
AD  - Department of Biological and Environmental Sciences, School of Life and Medical
      Sciences, University of Hertfordshire, Hatfield, Hertfordshire, United Kingdom.
FAU - Maldonado-Garza, Hector
AU  - Maldonado-Garza H
AD  - Servicio de Gastroenterologia, Hospital Universitario "Dr. Jose Eleuterio
      Gonzalez", Universidad Autonoma de Nuevo Leon, Monterrey, Nuevo Leon, Mexico.
FAU - Garza-Gonzalez, Elvira
AU  - Garza-Gonzalez E
AUID- ORCID: http://orcid.org/0000-0001-5831-9661
AD  - Servicio de Gastroenterologia, Hospital Universitario "Dr. Jose Eleuterio
      Gonzalez", Universidad Autonoma de Nuevo Leon, Monterrey, Nuevo Leon, Mexico.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20171220
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
RN  - 0 (RNA, Ribosomal, 16S)
RN  - 6Q205EH1VU (Vancomycin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Bacteria/genetics
MH  - Biodiversity
MH  - Clostridium Infections/drug therapy/*therapy
MH  - Demography
MH  - *Fecal Microbiota Transplantation
MH  - Feces/microbiology
MH  - Female
MH  - *Gastrointestinal Microbiome/genetics
MH  - Genotype
MH  - Humans
MH  - Male
MH  - Metagenomics
MH  - Microbial Sensitivity Tests
MH  - Middle Aged
MH  - Phylogeny
MH  - Principal Component Analysis
MH  - RNA, Ribosomal, 16S/genetics
MH  - Species Specificity
MH  - Tissue Donors
MH  - Vancomycin/therapeutic use
MH  - Young Adult
PMC - PMC5738078
EDAT- 2017/12/21 06:00
MHDA- 2018/01/09 06:00
CRDT- 2017/12/21 06:00
PHST- 2017/07/03 00:00 [received]
PHST- 2017/11/10 00:00 [accepted]
PHST- 2017/12/21 06:00 [entrez]
PHST- 2017/12/21 06:00 [pubmed]
PHST- 2018/01/09 06:00 [medline]
AID - 10.1371/journal.pone.0189768 [doi]
AID - PONE-D-17-20439 [pii]
PST - epublish
SO  - PLoS One. 2017 Dec 20;12(12):e0189768. doi: 10.1371/journal.pone.0189768.
      eCollection 2017.