Lack of efficacy of Lactobacillus GG in reducing pulmonary exacerbations and hospital admissions in children with cystic fibrosis: A randomised placebo controlled trial

Eugenia Bruzzese, Valeria Raia, Eliana Ruberto, Riccardo Scotto, Antonietta Giannattasio, Dario Bruzzese, Maria Cristina Cavicchi, Michela Francalanci, Carla Colombo, Nadia Faelli, Valeria Dacco`, Giuseppe Magazzu`, Stefano Costa, Vincenzina Lucidi, Fabio Majo, Alfredo Guarino

Research output: Contribution to journalArticle

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Abstract

Background: Intestinal dysbiosis has been described in Cystic Fibrosis (CF) and probiotics have been proposed to restore microbial composition. Aim of the study was to investigate the effects of Lactobacillus rhamnosus GG (LGG) on clinical outcomes in children with cystic fibrosis (CF). Methods: A multicentre, randomised double-blind, clinical trial was conducted in children with CF. After 6months of baseline assessment, enrolled children (2 to 16years of age) received Lactobacillus GG (6×109 CFU/day) or placebo for 12months. Primary outcomes were proportion of subjects with at least one pulmonary exacerbation and hospitalisation over 12months. Secondary endpoints were total number of exacerbations and hospitalisations, pulmonary function, and nutritional status. Results: Ninety-five patients were enrolled (51/95 female; median age of 103. ±. 50. months). In a multivariate GEE logistic analysis, the odds of experiencing at least one exacerbation was not significantly different between the two groups, also after adjusting for the presence of different microbial organisms and for the number of pulmonary exacerbations within 6. months before randomisation (OR 0.83; 95% CI 0.38 to 1.82, p = 0.643). Similarly, LGG supplementation did not significantly affect the odds of hospitalisations (OR 1.67; 95% CI 0.75 to 3.72, p = 0.211). No significant difference was found for body mass index and FEV1. Conclusions: LGG supplementation had no effect on respiratory and nutritional outcomes in this large study population of children with CF under stringent randomised clinical trial conditions. Whether earlier interventions, larger doses, or different strains of probiotics may be effective is unknown.

Original languageEnglish
Pages (from-to)375-382
JournalJournal of Cystic Fibrosis
Volume17
Issue number3
DOIs
Publication statusPublished - 2018

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Lactobacillus rhamnosus
Cystic Fibrosis
Randomized Controlled Trials
Placebos
Lung
Hospitalization
Probiotics
Dysbiosis
Random Allocation
Nutritional Status
Body Mass Index
Clinical Trials

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Pulmonary and Respiratory Medicine

Cite this

Lack of efficacy of Lactobacillus GG in reducing pulmonary exacerbations and hospital admissions in children with cystic fibrosis : A randomised placebo controlled trial. / Bruzzese, Eugenia; Raia, Valeria; Ruberto, Eliana; Scotto, Riccardo; Giannattasio, Antonietta; Bruzzese, Dario; Cavicchi, Maria Cristina; Francalanci, Michela; Colombo, Carla; Faelli, Nadia; Dacco`, Valeria; Magazzu`, Giuseppe; Costa, Stefano; Lucidi, Vincenzina; Majo, Fabio; Guarino, Alfredo.

In: Journal of Cystic Fibrosis, Vol. 17, No. 3, 2018, p. 375-382.

Research output: Contribution to journalArticle

Bruzzese, E, Raia, V, Ruberto, E, Scotto, R, Giannattasio, A, Bruzzese, D, Cavicchi, MC, Francalanci, M, Colombo, C, Faelli, N, Dacco`, V, Magazzu`, G, Costa, S, Lucidi, V, Majo, F & Guarino, A 2018, 'Lack of efficacy of Lactobacillus GG in reducing pulmonary exacerbations and hospital admissions in children with cystic fibrosis: A randomised placebo controlled trial', Journal of Cystic Fibrosis, vol. 17, no. 3, pp. 375-382. https://doi.org/10.1016/j.jcf.2017.10.014
Bruzzese, Eugenia ; Raia, Valeria ; Ruberto, Eliana ; Scotto, Riccardo ; Giannattasio, Antonietta ; Bruzzese, Dario ; Cavicchi, Maria Cristina ; Francalanci, Michela ; Colombo, Carla ; Faelli, Nadia ; Dacco`, Valeria ; Magazzu`, Giuseppe ; Costa, Stefano ; Lucidi, Vincenzina ; Majo, Fabio ; Guarino, Alfredo. / Lack of efficacy of Lactobacillus GG in reducing pulmonary exacerbations and hospital admissions in children with cystic fibrosis : A randomised placebo controlled trial. In: Journal of Cystic Fibrosis. 2018 ; Vol. 17, No. 3. pp. 375-382.
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abstract = "Background: Intestinal dysbiosis has been described in Cystic Fibrosis (CF) and probiotics have been proposed to restore microbial composition. Aim of the study was to investigate the effects of Lactobacillus rhamnosus GG (LGG) on clinical outcomes in children with cystic fibrosis (CF). Methods: A multicentre, randomised double-blind, clinical trial was conducted in children with CF. After 6months of baseline assessment, enrolled children (2 to 16years of age) received Lactobacillus GG (6×109 CFU/day) or placebo for 12months. Primary outcomes were proportion of subjects with at least one pulmonary exacerbation and hospitalisation over 12months. Secondary endpoints were total number of exacerbations and hospitalisations, pulmonary function, and nutritional status. Results: Ninety-five patients were enrolled (51/95 female; median age of 103. ±. 50. months). In a multivariate GEE logistic analysis, the odds of experiencing at least one exacerbation was not significantly different between the two groups, also after adjusting for the presence of different microbial organisms and for the number of pulmonary exacerbations within 6. months before randomisation (OR 0.83; 95{\%} CI 0.38 to 1.82, p = 0.643). Similarly, LGG supplementation did not significantly affect the odds of hospitalisations (OR 1.67; 95{\%} CI 0.75 to 3.72, p = 0.211). No significant difference was found for body mass index and FEV1. Conclusions: LGG supplementation had no effect on respiratory and nutritional outcomes in this large study population of children with CF under stringent randomised clinical trial conditions. Whether earlier interventions, larger doses, or different strains of probiotics may be effective is unknown.",
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T1 - Lack of efficacy of Lactobacillus GG in reducing pulmonary exacerbations and hospital admissions in children with cystic fibrosis

T2 - A randomised placebo controlled trial

AU - Bruzzese, Eugenia

AU - Raia, Valeria

AU - Ruberto, Eliana

AU - Scotto, Riccardo

AU - Giannattasio, Antonietta

AU - Bruzzese, Dario

AU - Cavicchi, Maria Cristina

AU - Francalanci, Michela

AU - Colombo, Carla

AU - Faelli, Nadia

AU - Dacco`, Valeria

AU - Magazzu`, Giuseppe

AU - Costa, Stefano

AU - Lucidi, Vincenzina

AU - Majo, Fabio

AU - Guarino, Alfredo

PY - 2018

Y1 - 2018

N2 - Background: Intestinal dysbiosis has been described in Cystic Fibrosis (CF) and probiotics have been proposed to restore microbial composition. Aim of the study was to investigate the effects of Lactobacillus rhamnosus GG (LGG) on clinical outcomes in children with cystic fibrosis (CF). Methods: A multicentre, randomised double-blind, clinical trial was conducted in children with CF. After 6months of baseline assessment, enrolled children (2 to 16years of age) received Lactobacillus GG (6×109 CFU/day) or placebo for 12months. Primary outcomes were proportion of subjects with at least one pulmonary exacerbation and hospitalisation over 12months. Secondary endpoints were total number of exacerbations and hospitalisations, pulmonary function, and nutritional status. Results: Ninety-five patients were enrolled (51/95 female; median age of 103. ±. 50. months). In a multivariate GEE logistic analysis, the odds of experiencing at least one exacerbation was not significantly different between the two groups, also after adjusting for the presence of different microbial organisms and for the number of pulmonary exacerbations within 6. months before randomisation (OR 0.83; 95% CI 0.38 to 1.82, p = 0.643). Similarly, LGG supplementation did not significantly affect the odds of hospitalisations (OR 1.67; 95% CI 0.75 to 3.72, p = 0.211). No significant difference was found for body mass index and FEV1. Conclusions: LGG supplementation had no effect on respiratory and nutritional outcomes in this large study population of children with CF under stringent randomised clinical trial conditions. Whether earlier interventions, larger doses, or different strains of probiotics may be effective is unknown.

AB - Background: Intestinal dysbiosis has been described in Cystic Fibrosis (CF) and probiotics have been proposed to restore microbial composition. Aim of the study was to investigate the effects of Lactobacillus rhamnosus GG (LGG) on clinical outcomes in children with cystic fibrosis (CF). Methods: A multicentre, randomised double-blind, clinical trial was conducted in children with CF. After 6months of baseline assessment, enrolled children (2 to 16years of age) received Lactobacillus GG (6×109 CFU/day) or placebo for 12months. Primary outcomes were proportion of subjects with at least one pulmonary exacerbation and hospitalisation over 12months. Secondary endpoints were total number of exacerbations and hospitalisations, pulmonary function, and nutritional status. Results: Ninety-five patients were enrolled (51/95 female; median age of 103. ±. 50. months). In a multivariate GEE logistic analysis, the odds of experiencing at least one exacerbation was not significantly different between the two groups, also after adjusting for the presence of different microbial organisms and for the number of pulmonary exacerbations within 6. months before randomisation (OR 0.83; 95% CI 0.38 to 1.82, p = 0.643). Similarly, LGG supplementation did not significantly affect the odds of hospitalisations (OR 1.67; 95% CI 0.75 to 3.72, p = 0.211). No significant difference was found for body mass index and FEV1. Conclusions: LGG supplementation had no effect on respiratory and nutritional outcomes in this large study population of children with CF under stringent randomised clinical trial conditions. Whether earlier interventions, larger doses, or different strains of probiotics may be effective is unknown.

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