Randomized clinical trial to evaluate the effect of fecal microbiota transplant for initial Clostridium difficile infection in intestinal microbiome

Green, John y Camacho Ortiz, Adrián y Gutiérrez Delgado, Eva María y Garcia Mazcorro, Jose F. y Mendoza Olazarán, Soraya Sarahí y Martíne Meléndez, Adrián y Palau Davila, Laura y Baines, Simon D. y Maldonado Garza, Héctor 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

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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.

Tipo de elemento: Article
Divisiones: Medicina
Usuario depositante: Lic. Jesús E. Alvarado
Creadores:
CreadorEmailORCID
Green, JohnNO ESPECIFICADONO ESPECIFICADO
Camacho Ortiz, AdriánNO ESPECIFICADONO ESPECIFICADO
Gutiérrez Delgado, Eva MaríaNO ESPECIFICADONO ESPECIFICADO
Garcia Mazcorro, Jose F.NO ESPECIFICADONO ESPECIFICADO
Mendoza Olazarán, Soraya SarahíNO ESPECIFICADONO ESPECIFICADO
Martíne Meléndez, AdriánNO ESPECIFICADONO ESPECIFICADO
Palau Davila, LauraNO ESPECIFICADONO ESPECIFICADO
Baines, Simon D.NO ESPECIFICADONO ESPECIFICADO
Maldonado Garza, HéctorNO ESPECIFICADONO ESPECIFICADO
Garza González, ElviraNO ESPECIFICADONO ESPECIFICADO
Fecha del depósito: 17 Jul 2018 18:22
Última modificación: 17 Jul 2018 18:22
URI: http://eprints.uanl.mx/id/eprint/14489

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