Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2014 Nov 19;9(1):58.
doi: 10.1186/2049-6958-9-58. eCollection 2014.

Clinical efficacy and tolerability of an immune-stimulant(*) constituted by inactivated bacterial bodies in the prophylaxis of infectious episodes of airways: a double blind, placebo-controlled, randomized, multicentre study

Stefano Carlone  1 , Michele Minenna  2 , Paride Morlino  3 , Luigi Mosca  4 , Franco Pasqua  5 , Riccardo Pela  6 , Pietro Schino  7 , Alberto Tubaldi  8 , Emmanuele Tupputi  9 , Fernando De Benedetto  10 ; Buccalin Trial Group
Affiliations

Clinical efficacy and tolerability of an immune-stimulant(*) constituted by inactivated bacterial bodies in the prophylaxis of infectious episodes of airways: a double blind, placebo-controlled, randomized, multicentre study

Stefano Carlone et al. Multidiscip Respir Med. .

Abstract

Background: (Buccalin ®) is a Bacterial Lysates (BL) that belongs to a family of immune-stimulators, developed more than 30 years ago and it still has a role in the prophylaxis of Recurrent Respiratory Tract Infections (RRTI). However, original studies were conducted with an approach that does not seem to be aligned with the present methodologies. In addition, concomitant therapies substantially improved in the last decades. These two reasons strongly suggested to update our knowledge on the capacity of this bacterial lysate (Buccalin ®) to reduce the number of days with infectious episodes in patients with RRTI.

Methods: A double blind, placebo-controlled, randomized, multicentre study was programmed (EudraCT code: 2011-005187-25). The reduction of the number of days with infectious episodes (IE) was the primary endpoint. Secondary endpoints were the number of IE, the use of concomitant drugs, the efficacy on signs and symptoms of RRTI and the safety of the drug. Patients were treated according to the registered schedule and were followed up for a period of 6 months.

Results: From a cohort of 188 patients eligible for the study, 90 were included in the active group and 88 in the placebo group. The study was completed in 170 patients. A significant reduction of the number of days with IE was observed (6.57 days in the active group and 7.47 in the placebo group). Secondary endpoints were only partially achieved. No virtual adverse events related to the treatment were recorded.

Conclusion: The administration of bacterial lysate (Buccalin ®) in patients with RRTI had the capacity to significantly reduce the number of days with IE in a multicentre, randomized, placebo controlled, clinical study. The treatment was safe. Of note, all patients were free to be treated with the best concomitant therapies. In these conditions, the positive results observed demonstrated that this bacterial lysate has maintained its capacity of reducing the days with infections in patients with RRTI, also in association to the concomitant therapies available nowadays.

Keywords: Bacterial lysates; Immune-stimulation; Placebo-controlled trial; Recurrent respiratory infections.

PubMed Disclaimer

Similar articles

See all similar articles

Cited by

References

    1. van de Pol AC, van der Gugten AC, van der Ent CK, Schilder AG, Benthem EM, Smit HA, Stellato RK, De Wit NJ, Damoiseaux RA. Referrals for recurrent respiratory tract infections including otitis media in young children. Int J Pediatr Otorhinolaryngol. 2013;77(6):906–910. doi: 10.1016/j.ijporl.2013.03.003. - DOI - PubMed
    1. Esposito S, Musio A. Immunostimulants and prevention of recurrent respiratory tract infections. J Biol Regul Homeost Agents. 2013;27(3):627–636. - PubMed
    1. Villa E, Garelli V, Braido F, Melioli G, Canonica GW. May we strengthen the human natural defenses with bacterial lysates? World Allergy Organ J. 2010;3(8 Suppl):S17–S23. - PMC - PubMed
    1. Cazzola M, Anapurapu S, Page CP. Polyvalent mechanical bacterial lysate for the prevention of recurrent respiratory infections: a meta-analysis. Pulm Pharmacol Ther. 2012;25(1):62–68. doi: 10.1016/j.pupt.2011.11.002. - DOI - PubMed
    1. De Benedetto F, Sevieri G. Prevention of respiratory tract infections with bacterial lysate OM-85 bronchomunal in children and adults: a state of the art. Multidiscip Resp Med. 2013;8:33. doi: 10.1186/2049-6958-8-33. - DOI - PMC - PubMed

LinkOut - more resources