The bacterial lysate Lantigen B reduces the number of acute episodes in patients with recurrent infections of the respiratory tract: The results of a double blind, placebo controlled, multicenter clinical trial

Abstract

Studies in the 1970s and 1980s reported that bacterial lysates (BL) had a prophylactic effect on recurrent respiratory tract infections (RRTI). However, controlled clinical study procedures have evolved substantially since then. We performed a trial using updated methods to evaluate the efficacy of Lantigen B®, a chemical BL. This double blind, placebo controlled, multi-center clinical trial had the primary objective of assessing the capacity of Lantigen B to significantly reduce the total number of infectious episodes in patients with RRTI. Secondary aims were the RRTI duration, the frequency and the severity of the acute episodes, the use of drugs and the number of missed workdays. In the subgroup of allergic patients with RRTI, the number of allergic episodes (AE) and the use of anti-allergic drugs were also evaluated. One hundred and sixty patients, 79 allocated to the treated group (TG) and 81 to the placebo group (PG), were enrolled; 30 were lost during the study and 120 (79 females and 38 males) were evaluated. The PG had 1.43 episodes in the 8-months of follow-up while the TG had 0.86 episodes (p=0.036). A similar result was observed in the allergic patients (1.80 and 0.86 episodes for the PG and the TG, respectively, p=0.047). The use of antibiotics was reduced (mean 1.24 and 2.83 days of treatment for the TG and the PG). Logistic regression analysis indicated that the estimated risk of needing antibiotics and NSAIDs was reduced by 52.1 and 30.6%, respectively. With regard to the number of AE, no significant difference was observed between the two groups, but bronchodilators, antihistamines and local corticosteroids were reduced by 25.7%, 56.2% and 41.6%, respectively, in the TG. Lantigen B significantly reduced the number of infectious episodes in patients with RRTI. This finding suggests a first line use of this drug for the prophylaxis of infectious episodes in these patients.

The International Scientific Association of Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of postbiotics

“…ozaenae, two strains of Staphylococcus aureus, one strain of Streptococcus pyogenes, three strains of Streptococcus sanguinis and three strains of Moraxella catarrhalis. Bacterial lysates have further been shown to exert anti infection effects 34 and, indeed, efficacy in reduc ing the frequency of acute respiratory infections among those prone to recurrent respiratory infections has been demonstrated in clinical trials 34,35 . In addition, polyvalent bacterial lysates derived from the mechan ical lysis of strains commonly involved in respiratory infections such as otitis media, pharyngitis, sinusitis and sometimes pneumonia induced the maturation of dendritic cells, recruit B and T lymphocytes, increase the number of circulating natural killer cells in treated patients when compared with age matched controls 30 and induced the secretion of specific IgA [36][37][38] in a group of ten healthy volunteers, suggesting some potential in the treatment of chronic pulmonary conditions such as chronic obstructive pulmonary disease.…”

Characterization of Bacterial Lysates by Use of Matrix-Assisted Laser Desorption– Ionization Time of Flight Mass Spectrometry Fingerprinting

“…Because of the clinical relevance of respiratory infections and the importance of the development of new immunization antigens, bacterial lysates used individually or as combination of them (polyvalent) have recently gained new interest due to their capacity to induce a range of effects on the immune system by reducing the level of colonization [4,5]. Although their safety levels are considered acceptable, as are their anti-infective properties, there have been claims that fuller understanding of their mechanism of action is needed, as well as a detailed description of their effects.…”

Bacterial Lysates as Immunotherapies for Respiratory Infections: Methods of Preparation

“…Rosaschino and Cattaneo (2004) evaluated efficacy and tolerance in pediatric patients treated with PMBL and demonstrated that the treatment was effective with excellent tolerability of the BLs (Rosaschino and Cattaneo, 2004). Braido and Melioli studied another lysate preparation named Lantigen B in patients with recurrent RTIs and demonstrated a significant reduction of the number of acute episodes in these patients (Braido et al, 2014).…”

“…One of the first bacterial lysates obtained by alkaline extraction was Lantigen B whose in vivo effects were first described in the 1970s (Tyrrell et al, 1972) and more recently demonstrated by Braido et al (2014). Later on, Bauer et al (1995) patented another process that included cultivation of Escherichia coli in an aqueous medium followed by alkaline extraction of bacterial proteins, in the presence of a "diluted aqueous source of OHions."…”