A randomized clinical trial on the effectiveness of a symbiotic product to decolonize patients harboring multidrug-resistant Gram-negative bacilli
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 clinica...
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ftdoajarticles:oai:doaj.org/article:ed84afe8ccc34a3db94192e4fa3d6896 2023-05-15T15:12:00+02:00 A randomized clinical trial on the effectiveness of a symbiotic product to decolonize patients harboring multidrug-resistant Gram-negative bacilli Mariana Correa Coelho Salomão Mário Augusto Heluany-Filho Mayra Gonçalves Menegueti Marlieke Elizabeth Adriana De Kraker Roberto Martinez Fernando Bellissimo-Rodrigues https://doi.org/10.1590/0037-8682-0233-2016 https://doaj.org/article/ed84afe8ccc34a3db94192e4fa3d6896 EN eng Sociedade Brasileira de Medicina Tropical (SBMT) http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0037-86822016000500559&lng=en&tlng=en https://doaj.org/toc/1678-9849 1678-9849 doi:10.1590/0037-8682-0233-2016 https://doaj.org/article/ed84afe8ccc34a3db94192e4fa3d6896 Revista da Sociedade Brasileira de Medicina Tropical, Vol 49, Iss 5, Pp 559-566 Probiotic Lactobacillus Symbiotic Decolonization Antimicrobial resistance Arctic medicine. Tropical medicine RC955-962 article ftdoajarticles https://doi.org/10.1590/0037-8682-0233-2016 2022-12-30T23:08:23Z 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. Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic Revista da Sociedade Brasileira de Medicina Tropical 49 5 559 566 |
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Directory of Open Access Journals: DOAJ Articles |
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English |
topic |
Probiotic Lactobacillus Symbiotic Decolonization Antimicrobial resistance Arctic medicine. Tropical medicine RC955-962 |
spellingShingle |
Probiotic Lactobacillus Symbiotic Decolonization Antimicrobial resistance Arctic medicine. Tropical medicine RC955-962 Mariana Correa Coelho Salomão Mário Augusto Heluany-Filho Mayra Gonçalves Menegueti Marlieke Elizabeth Adriana De Kraker Roberto Martinez Fernando Bellissimo-Rodrigues A randomized clinical trial on the effectiveness of a symbiotic product to decolonize patients harboring multidrug-resistant Gram-negative bacilli |
topic_facet |
Probiotic Lactobacillus Symbiotic Decolonization Antimicrobial resistance Arctic medicine. Tropical medicine RC955-962 |
description |
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. |
format |
Article in Journal/Newspaper |
author |
Mariana Correa Coelho Salomão Mário Augusto Heluany-Filho Mayra Gonçalves Menegueti Marlieke Elizabeth Adriana De Kraker Roberto Martinez Fernando Bellissimo-Rodrigues |
author_facet |
Mariana Correa Coelho Salomão Mário Augusto Heluany-Filho Mayra Gonçalves Menegueti Marlieke Elizabeth Adriana De Kraker Roberto Martinez Fernando Bellissimo-Rodrigues |
author_sort |
Mariana Correa Coelho Salomão |
title |
A randomized clinical trial on the effectiveness of a symbiotic product to decolonize patients harboring multidrug-resistant Gram-negative bacilli |
title_short |
A randomized clinical trial on the effectiveness of a symbiotic product to decolonize patients harboring multidrug-resistant Gram-negative bacilli |
title_full |
A randomized clinical trial on the effectiveness of a symbiotic product to decolonize patients harboring multidrug-resistant Gram-negative bacilli |
title_fullStr |
A randomized clinical trial on the effectiveness of a symbiotic product to decolonize patients harboring multidrug-resistant Gram-negative bacilli |
title_full_unstemmed |
A randomized clinical trial on the effectiveness of a symbiotic product to decolonize patients harboring multidrug-resistant Gram-negative bacilli |
title_sort |
randomized clinical trial on the effectiveness of a symbiotic product to decolonize patients harboring multidrug-resistant gram-negative bacilli |
publisher |
Sociedade Brasileira de Medicina Tropical (SBMT) |
url |
https://doi.org/10.1590/0037-8682-0233-2016 https://doaj.org/article/ed84afe8ccc34a3db94192e4fa3d6896 |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
Revista da Sociedade Brasileira de Medicina Tropical, Vol 49, Iss 5, Pp 559-566 |
op_relation |
http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0037-86822016000500559&lng=en&tlng=en https://doaj.org/toc/1678-9849 1678-9849 doi:10.1590/0037-8682-0233-2016 https://doaj.org/article/ed84afe8ccc34a3db94192e4fa3d6896 |
op_doi |
https://doi.org/10.1590/0037-8682-0233-2016 |
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Revista da Sociedade Brasileira de Medicina Tropical |
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49 |
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559 |
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