A randomized clinical trial on the effectiveness of a symbiotic product to decolonize patients harboring multidrug-resistant Gram-negative bacilli
Rev. Soc. Bras. Med. Trop
;
49(5): 559-566, Sept.-Oct. 2016. tab, graf
Artículo
en Inglés
| LILACS
| ID: lil-798126
ABSTRACT
Abstract INTRODUCTION:
We aimed to evaluate the effectiveness of a symbiotic product to decolonize the intestinal tract of patients harboring multidrug-resistant (MDR) Gram-negative bacilli and to prevent nosocomial infections.METHODS:
This was a randomized, double blind, placebo-controlled clinical trial, conducted in a tertiary-care university hospital. All adult hospitalized patients with a positive clinical culture and a positive rectal swab for any MDR Gram-negative bacilli were potentially eligible. Exclusion criteria were pregnancy, immunosuppression, and bowel obstruction/perforation. The intervention consisted of administering a symbiotic product (Lactobacillus bulgaricus, Lactobacillus rhamnosus, and fructo-oligosaccharides) twice a day for seven days via the oral/enteral route.RESULTS:
Between August 1, 2012 and December 22, 2013, 116 of 275 eligible patients were allocated to treatment (n=57) and placebo (n=59). Overall, 101 patients received at least four doses of the study products and were included in the modified intention-to-treat analysis. The primary study outcome, a negative rectal swab for MDR Gram-negative bacilli after treatment, was identified in 16.7% (8/48) and 20.7% (11/53) of patients in the experimental and placebo group, respectively (p=0.60). The secondary outcome, the combined incidence of nosocomial respiratory and urinary tract infections, was 37.5% (18/48) in the experimental group versus 22.6% (12/53) in the control group (adjusted odds ratio 1.95, 95% confidence interval 0.69-5.50, p=0.21). Length of stay after the beginning of the intervention, incidence of adverse events, and in-hospital mortality rates were similar in both study groups.CONCLUSIONS:
Under the present study conditions, symbiotic administration was not effective for decolonizing hospitalized patients harboring MDR Gram-negative bacilli.
Texto completo:
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Índice:
LILACS (Américas)
Asunto principal:
Infección Hospitalaria
/
Infecciones por Bacterias Gramnegativas
/
Probióticos
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Farmacorresistencia Bacteriana Múltiple
/
Bacterias Gramnegativas
Tipo de estudio:
Ensayo Clínico Controlado
/
Estudio pronóstico
Límite:
Adulto
/
Anciano
/
Femenino
/
Humanos
/
Masculino
Idioma:
Inglés
Revista:
Rev. Soc. Bras. Med. Trop
Asunto de la revista:
Medicina Tropical
Año:
2016
Tipo del documento:
Artículo
País de afiliación:
Brasil
Institución/País de afiliación:
Universidade de São Paulo/BR
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