OM-85

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OM-85
Clinical data
Trade names Broncho-Vaxom
Other namesOM 85BV
Identifiers
CAS Number

OM-85 or OM85 (trade name Broncho-Vaxom) is an immunostimulant. It is a combination of molecules extracted from the walls of bacteria that commonly cause respiratory infections. [1]

Contents

Uses

It has been sold, as Broncho-Vaxom, in Europe and some South American countries. [1] It is used for children with asthma or recurrent respiratory infections. [1]

Studies have shown that OM-85 can enhance both innate and adaptive immunity by promoting the maturation of dendritic cells in the gastrointestinal Peyer's patches, which in turn strengthens immune defenses in the lung mucosa. [2]

It can also reduce inflammation. This is achieved through the reduction of pro-inflammatory cytokines and the increase of anti-inflammatory cytokines. [2]

Potential uses

It may help prevent Covid-19. [3]

It may prevent babies from developing asthma. [4] [5]

Composition

It is a mix of lipopolysaccharides, [5] extracted from bacteria cell walls. These include Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae, Klebsiella ozaenae, Staphylococcus aureus, Streptococcus pyogenes, Streptococcus sanguinis, and Moraxella catarrhalis. [2]

Clinical trials

It has been studied in numerous pediatric clinical trials. [3]

Adults

A randomized, double-blind, placebo-controlled study in 396 patients with chronic bronchitis demonstrated a 28% reduction in RIs (Respiratory Tract Infections [2] ) in patients treated with OM-85, associated with a reduction in antibiotic prescriptions, and no increase in adverse events. [2]

In a randomized, double-blind, placebo-controlled 6-month study performed in 381 patients with severe COPD and a long smoking history, OM-85 induced a 55% reduction in the number of hospitalization days for respiratory diseases compared to placebo. [2]

A subsequent randomized, double-blind, placebo-controlled trial in 273 patients aged >40 years with recently diagnosed chronic bronchitis or COPD and current exacerbation showed that the exacerbation rate was reduced by 29% with OM-85 compared to placebo. This reduction was more pronounced in patients who were smokers or ex-smokers, showing a 40% lower mean rate of exacerbation vs. placebo. [2]

A more recent study demonstrated the ability of OM-85 to protect COPD patients from exacerbations by significantly reducing the percentage of patients with exacerbations after 12 weeks of treatment and maintaining its beneficial effect until 22 weeks, with a positive tolerability profile. [2]

Children

The use of OM-85 for 10 consecutive days every month for 3 months was shown to reduce the risk of RRIs (Recurrent Respiratory Infection [2] ) in children, with a favorable safety profile. The protective effect was highest in children with the highest risk, suggesting that OM-85 administration might be particularly useful and should be recommended in these subjects. [2]

A prospective, randomized, single-blind study in 68 children aged 36–59 months treated with OM-85 for 3 months with 10-day cycles and receiving influenza vaccine 15 days after the first cycle demonstrated a more pronounced reduction of upper and lower respiratory tract infections. Moreover, a reduction in antibiotic use and the number of missed school days was recorded, with no interference of OM-85 on the immune response against the influenza vaccine and no increase in adverse events. [2]

In a randomized, double-blind placebo-controlled study performed in children aged 6–13 years with ≥3 acute episodes of RIs in the 6 months before enrollment, treatment with OM-85 for 6 months induced a 52% reduction in the number of infections compared to placebo. OM-85 use was also associated with a reduction in antibiotic use, days of illness, and school absenteeism, with no increase in adverse events. [2]

A randomized, double-blind placebo-controlled study in 75 pre-school children with a history of frequent wheezing episodes demonstrated that a single OM-85 course reduced both rhinopharyngitis and wheezing episodes by 38% over 12 months, with a significant reduction in the cumulative frequency of wheezing episodes compared to placebo and in the percentage of patients using antibiotics. [2]

Related Research Articles

<span class="mw-page-title-main">Asthma</span> Long-term inflammatory disease of the airways of the lungs

Asthma is a long-term inflammatory disease of the airways of the lungs. It is characterized by variable and recurring symptoms, reversible airflow obstruction, and easily triggered bronchospasms. Symptoms include episodes of wheezing, coughing, chest tightness, and shortness of breath. These may occur a few times a day or a few times per week. Depending on the person, asthma symptoms may become worse at night or with exercise.

<span class="mw-page-title-main">Pneumonia</span> Inflammation of the alveoli of the lungs

Pneumonia is an inflammatory condition of the lung primarily affecting the small air sacs known as alveoli. Symptoms typically include some combination of productive or dry cough, chest pain, fever, and difficulty breathing. The severity of the condition is variable.

<span class="mw-page-title-main">Sputum</span> Mucus that is coughed up from the lower airways

Sputum is mucus that is coughed up from the lower airways. In medicine, sputum samples are usually used for a naked eye examination, microbiological investigation of respiratory infections and cytological investigations of respiratory systems. It is crucial that the specimen does not include any mucoid material from the nose or oral cavity.

<span class="mw-page-title-main">Acute bronchitis</span> Medical condition

Acute bronchitis, also known as a chest cold, is short-term bronchitis – inflammation of the bronchi of the lungs. The most common symptom is a cough. Other symptoms include coughing up mucus, wheezing, shortness of breath, fever, and chest discomfort. The infection may last from a few to ten days. The cough may persist for several weeks afterward with the total duration of symptoms usually around three weeks. Some have symptoms for up to six weeks.

<span class="mw-page-title-main">Respiratory syncytial virus</span> Species of virus

Respiratory syncytial virus (RSV), also called human respiratory syncytial virus (hRSV) and human orthopneumovirus, is a contagious virus that causes infections of the respiratory tract. It is a negative-sense, single-stranded RNA virus. Its name is derived from the large cells known as syncytia that form when infected cells fuse.

<span class="mw-page-title-main">Upper respiratory tract infection</span> Infection of the nose, sinuses, pharynx, larynx or trachea

An upper respiratory tract infection (URTI) is an illness caused by an acute infection, which involves the upper respiratory tract, including the nose, sinuses, pharynx, larynx or trachea. This commonly includes nasal obstruction, sore throat, tonsillitis, pharyngitis, laryngitis, sinusitis, otitis media, and the common cold. Most infections are viral in nature, and in other instances, the cause is bacterial. URTIs can also be fungal or helminthic in origin, but these are less common.

<span class="mw-page-title-main">Lower respiratory tract infection</span> Medical term

Lower respiratory tract infection (LRTI) is a term often used as a synonym for pneumonia but can also be applied to other types of infection including lung abscess and acute bronchitis. Symptoms include shortness of breath, weakness, fever, coughing and fatigue. A routine chest X-ray is not always necessary for people who have symptoms of a lower respiratory tract infection.

<i>Chlamydia pneumoniae</i> Species of bacterium

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<span class="mw-page-title-main">Bronchoconstriction</span> Constriction of the terminal airways in the lungs

Bronchoconstriction is the constriction of the airways in the lungs due to the tightening of surrounding smooth muscle, with consequent coughing, wheezing, and shortness of breath.

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<span class="mw-page-title-main">Acute exacerbation of chronic obstructive pulmonary disease</span> Medical condition

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References

  1. 1 2 3 Sly P (11 June 2020). "M85: could bacteria in a capsule protect us from coronavirus and other respiratory infections?".
  2. 1 2 3 4 5 6 7 8 9 10 11 12 13 Esposito S, Cassano M, Cutrera R, Menzella F, Varricchio A, Uberti M (November 2022). "Expert consensus on the role of OM-85 in the management of recurrent respiratory infections: A Delphi study". Human Vaccines & Immunotherapeutics. 18 (6): 2106720. doi:10.1080/21645515.2022.2106720. PMC   9746428 . PMID   35985019.
  3. 1 2 Cao C, Wang J, Li Y, Li Y, Ma L, Abdelrahim ME, et al. (May 2021). "Efficacy and safety of OM-85 in paediatric recurrent respiratory tract infections which could have a possible protective effect on COVID-19 pandemic: A meta-analysis". International Journal of Clinical Practice. 75 (5): e13981. doi:10.1111/ijcp.13981. PMC   7883224 . PMID   33405321.
  4. ↑ Hart A (15 Feb 2022). "Aussie researchers make asthma breakthrough".
  5. 1 2 Troy NM, Strickland D, Serralha M, de Jong E, Jones AC, Read J, et al. (July 2022). "Protection against severe infant lower respiratory tract infections by immune training: Mechanistic studies". The Journal of Allergy and Clinical Immunology. 150 (1): 93–103. doi: 10.1016/j.jaci.2022.01.001 . hdl: 10044/1/95014 . PMID   35177255. S2CID   246844791.
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