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A randomized clinical trial on the effectiveness of a symbiotic product to decolonize patients harboring multidrug-resistant Gram-negative bacilli
Salomão, Mariana Correa Coelho; Heluany-Filho, Mário Augusto; Menegueti, Mayra Gonçalves; Kraker, Marlieke Elizabeth Adriana De; Martinez, Roberto; Bellissimo-Rodrigues, Fernando.
  • Salomão, Mariana Correa Coelho; Universidade de São Paulo. Faculdade de Medicina de Ribeirão Preto. Departamento de Medicina Social. Ribeirão Preto. BR
  • Heluany-Filho, Mário Augusto; Universidade de São Paulo. Faculdade de Medicina de Ribeirão Preto. Departamento de Medicina Social. Ribeirão Preto. BR
  • Menegueti, Mayra Gonçalves; Universidade de São Paulo. Faculdade de Medicina de Ribeirão Preto. Departamento de Medicina Social. Ribeirão Preto. BR
  • Kraker, Marlieke Elizabeth Adriana De; Universidade de São Paulo. Faculdade de Medicina de Ribeirão Preto. Departamento de Medicina Social. Ribeirão Preto. BR
  • Martinez, Roberto; Universidade de São Paulo. Faculdade de Medicina de Ribeirão Preto. Departamento de Medicina Social. Ribeirão Preto. BR
  • Bellissimo-Rodrigues, Fernando; Universidade de São Paulo. Faculdade de Medicina de Ribeirão Preto. Departamento de Medicina Social. Ribeirão Preto. BR
Rev. Soc. Bras. Med. Trop ; 49(5): 559-566, Sept.-Oct. 2016. tab, graf
Article in English | 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.
Subject(s)


Full text: Available Index: LILACS (Americas) Main subject: Cross Infection / Gram-Negative Bacterial Infections / Probiotics / Drug Resistance, Multiple, Bacterial / Gram-Negative Bacteria Type of study: Controlled clinical trial / Prognostic study Limits: Adult / Aged / Female / Humans / Male Language: English Journal: Rev. Soc. Bras. Med. Trop Journal subject: Tropical Medicine Year: 2016 Type: Article Affiliation country: Brazil Institution/Affiliation country: Universidade de São Paulo/BR

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Full text: Available Index: LILACS (Americas) Main subject: Cross Infection / Gram-Negative Bacterial Infections / Probiotics / Drug Resistance, Multiple, Bacterial / Gram-Negative Bacteria Type of study: Controlled clinical trial / Prognostic study Limits: Adult / Aged / Female / Humans / Male Language: English Journal: Rev. Soc. Bras. Med. Trop Journal subject: Tropical Medicine Year: 2016 Type: Article Affiliation country: Brazil Institution/Affiliation country: Universidade de São Paulo/BR