Trial of an oral bacterial antigen against common colds.

Tyrrell, D. A. J.; Nolan, P. S.; Reed, Sylvia E.; Healy, M. J. R.

doi:10.1136/jech.26.2.129

Cited by 8 publications

(3 citation statements)

References 5 publications

(1 reference statement)

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“…It was evident that the treatment with Lantigen B did not significantly alter the number of allergic episodes or the number of days with allergy. This finding was not expected even if the strict correlation between the allergy symptoms and respiratory infectious diseases could suggest a potential positive effect [20]. A certain effect was observed, as a trend, in the use of anti-allergy drugs: indeed, in allergic patients, logistic regression showed that the probability of using drugs specific for allergy was reduced.…”

Section: Discussionmentioning

confidence: 88%

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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

Braido

Melioli

Candoli³

et al. 2014

Immunology Letters

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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.

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Section: Discussionmentioning

confidence: 88%

“…In addition, in the same studies, the reduction of cough, of lost days and antibiotics use was also observed. Of note, only one non-positive study on the common cold [20] was published, while all the others demonstrated the efficacy of the treatment.…”

Section: Introductionmentioning

confidence: 99%

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

Braido

Melioli

Candoli³

et al. 2014

Immunology Letters

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“…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."…”

Section: Types Of Bacterial Lysates Alkaline Bacterial Lysatesmentioning

confidence: 99%

Bacterial Lysates as Immunotherapies for Respiratory Infections: Methods of Preparation

Suárez

Ferrara

Rial

et al. 2020

Front. Bioeng. Biotechnol.

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Bacterial lysates, prepared from the microorganisms most frequently involved in human Respiratory Tract Infections (RTIs) have been in the market for several decades, and at present, several different brands are available in many countries worldwide. They all claimed to exert local and systemic immunomodulatory effects but different clinical trials show disparate results between them. The lack of consistency of predicted therapeutic effects has undermined their clinical use and hampered licensing in several countries. One explanation for such lack of consistency in the results is that their methods of preparation are also very different. Here, we review the available literature describing methods of preparation of bacterial lysates, including patent disclosure documents. We found a great variety of methodologies of preparation and a lack of standardized procedures among them. The main conclusion of our study is that there is a clear need for standardized protocols of production to obtain comparable results in clinical trials worldwide.

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