Randomized clinical trial to evaluate the effect of fecal microbiota transplant for initial Clostridium difficile infection in intestinal microbiome
Objective The aim of this study was to evaluate the impact of fecal donor-unrelated donor mix (FMTFURM) 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 d...
| Autores principales: | , , , , , , , , , |
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| Formato: | Artículo |
| Lenguaje: | inglés |
| Publicado: |
Public Library of Science
2017
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| Acceso en línea: | http://eprints.uanl.mx/14489/1/11.pdf |
| _version_ | 1824414059990089728 |
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| author | Green, John Camacho Ortiz, Adrián Gutiérrez Delgado, Eva María García Mazcorro, José Francisco Mendoza Olazarán, Soraya Sarahí Martíne Meléndez, Adrián Palau Davila, Laura Baines, Simon D. Maldonado Garza, Héctor Jesús Garza González, Elvira |
| author_facet | Green, John Camacho Ortiz, Adrián Gutiérrez Delgado, Eva María García Mazcorro, José Francisco Mendoza Olazarán, Soraya Sarahí Martíne Meléndez, Adrián Palau Davila, Laura Baines, Simon D. Maldonado Garza, Héctor Jesús Garza González, Elvira |
| author_sort | Green, John |
| collection | Repositorio Institucional |
| description | Objective The aim of this study was to evaluate the impact of fecal donor-unrelated donor mix (FMTFURM) 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. |
| format | Article |
| id | eprints-14489 |
| institution | UANL |
| language | English |
| publishDate | 2017 |
| publisher | Public Library of Science |
| record_format | eprints |
| spelling | eprints-144892024-12-10T19:37:43Z http://eprints.uanl.mx/14489/ Randomized clinical trial to evaluate the effect of fecal microbiota transplant for initial Clostridium difficile infection in intestinal microbiome Green, John Camacho Ortiz, Adrián Gutiérrez Delgado, Eva María García Mazcorro, José Francisco Mendoza Olazarán, Soraya Sarahí Martíne Meléndez, Adrián Palau Davila, Laura Baines, Simon D. Maldonado Garza, Héctor Jesús Garza González, Elvira Objective The aim of this study was to evaluate the impact of fecal donor-unrelated donor mix (FMTFURM) 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. Public Library of Science 2017 Article PeerReviewed text en cc_by_nc_nd http://eprints.uanl.mx/14489/1/11.pdf http://eprints.uanl.mx/14489/1.haspreviewThumbnailVersion/11.pdf Green, John y Camacho Ortiz, Adrián y Gutiérrez Delgado, Eva María y García Mazcorro, José Francisco y Mendoza Olazarán, Soraya Sarahí y Martíne Meléndez, Adrián y Palau Davila, Laura y Baines, Simon D. y Maldonado Garza, Héctor Jesús y Garza González, Elvira (2017) Randomized clinical trial to evaluate the effect of fecal microbiota transplant for initial Clostridium difficile infection in intestinal microbiome. PloS one, 12 (12). pp. 1-19. ISSN 1932-6203 doi:10.1371/journal.pone.0189768 |
| spellingShingle | Green, John Camacho Ortiz, Adrián Gutiérrez Delgado, Eva María García Mazcorro, José Francisco Mendoza Olazarán, Soraya Sarahí Martíne Meléndez, Adrián Palau Davila, Laura Baines, Simon D. Maldonado Garza, Héctor Jesús Garza González, Elvira Randomized clinical trial to evaluate the effect of fecal microbiota transplant for initial Clostridium difficile infection in intestinal microbiome |
| thumbnail | https://rediab.uanl.mx/themes/sandal5/images/online.png |
| title | Randomized clinical trial to evaluate the effect of fecal microbiota transplant for initial Clostridium difficile infection in intestinal microbiome |
| title_full | Randomized clinical trial to evaluate the effect of fecal microbiota transplant for initial Clostridium difficile infection in intestinal microbiome |
| title_fullStr | Randomized clinical trial to evaluate the effect of fecal microbiota transplant for initial Clostridium difficile infection in intestinal microbiome |
| title_full_unstemmed | Randomized clinical trial to evaluate the effect of fecal microbiota transplant for initial Clostridium difficile infection in intestinal microbiome |
| title_short | Randomized clinical trial to evaluate the effect of fecal microbiota transplant for initial Clostridium difficile infection in intestinal microbiome |
| title_sort | randomized clinical trial to evaluate the effect of fecal microbiota transplant for initial clostridium difficile infection in intestinal microbiome |
| url | http://eprints.uanl.mx/14489/1/11.pdf |
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