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Lactobacillus reuteri ATCC55730 in Cystic Fibrosis

Di Nardo, Giovanni*; Oliva, Salvatore*; Menichella, Alessandra; Pistelli, Riccardo; Biase, Riccardo Valerio De; Patriarchi, Francesca; Cucchiara, Salvatore*; Stronati, Laura§

Journal of Pediatric Gastroenterology & Nutrition: January 2014 - Volume 58 - Issue 1 - p 81–86
doi: 10.1097/MPG.0000000000000187
Original Articles: Hepatology and Nutrition

Objectives: The aim of this study was to evaluate in patients with cystic fibrosis (CF) the effect of Lactobacillus reuteri (LR) on the rate of respiratory exacerbations and of the infections of both upper respiratory and gastrointestinal tracts.

Methods: Prospective randomized, double-blind, placebo-controlled study enrolling 61 patients with CF with mild-to-moderate lung disease at the Regional Center for CF of the Department of Pediatrics, University of Rome “La Sapienza.” All of the patients were not hospital inpatients at the time of the enrollment. Inclusion criteria were forced expiratory volume in the first second (FEV1) >70% predicted; no inhaled or systemic steroids, no anti-inflammatory drugs, antileukotrienes, and mast cell membrane stabilizers; and no serious organ involvement. Exclusion criteria were a history of pulmonary exacerbation or upper respiratory infection in the previous 2 months; changes in medications in the last 2 months; a history of hemoptysis in the last 2 months; and colonization with Burkholderia cepacia or mycobacteria. Patients were randomly assigned to receive LR (30 patients) in 5 drops per day (1010 colony-forming units) or placebo (31 patients) for 6 months. Main outcomes were number of episodes of pulmonary exacerbations and hospital admissions for pulmonary exacerbations, number of gastrointestinal and upper respiratory tract infections. FEV1, fecal calprotectin, and cytokine profile in induced sputum and plasma were assessed at baseline and at the end of the trial.

Results: Pulmonary exacerbations were significantly reduced in the LR group compared with the placebo group (P < 0.01; odds ratio 0.06 [95% confidence interval {CI} 0–0.40]; number needed to treat 3 [95% CI 2–7]). Similarly, the number of upper respiratory tract infections (in our series only otitis) was significantly reduced in the LR group compared with the placebo group (P < 0.05; odds ratio 0.14 [95% CI 0–0.96]; number needed to treat 6 [95% CI 3–102]). The 2 groups did not differ statistically in the mean number and duration of hospitalizations for pulmonary exacerbations and gastrointestinal infections. There was no significant statistical difference in the mean delta value of FEV1, fecal calprotectin concentration, and tested cytokines (tumor necrosis factor-α and interleukin-8) between the 2 groups.

Conclusions: LR reduces pulmonary exacerbations and upper respiratory tract infections in patients with CF with mild-to-moderate lung disease. LR administration may have a beneficial effect on the disease course of CF.

*Department of Pediatrics, Pediatric Gastroenterology and Liver Unit

Regional Center for Cystic Fibrosis, University of Rome “La Sapienza,”

Department of Internal Medicine and Geriatrics, Catholic University of “Sacro Cuore,”

§ENEA, Italian National Agency for New Technologies, Energy and Sustainable Economic Development, Rome, Italy.

Address correspondence and reprint requests to Laura Stronati, PhD, Section of Toxicology and Biomedical Sciences, Italian National Agency for New Technologies, Energy and Sustainable Economic Development, ENEA–Via Anguillarese 301, 00123 Rome, Italy (e-mail: laura.stronati@enea.it).

Received 16 October, 2012

Accepted 17 September, 2013

This article has been developed as a Journal CME Activity by NASPGHAN. Visithttp://www.naspghan.org/wmspage.cfm?parm1=742 to view instructions, documentation, and the complete necessary steps to receive CME credit for reading this article.

http://www.clinicaltrials.gov registration number: NCT01737983.

The first 2 authors contributed equally to the study.

The authors report no conflicts of interest.

© 2014 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,