PMBL Website

PMBL results meta-analysis

The meta-analysis performed on PMBL demonstrated a significant reduction of infections during the 3 months treatment as compared to placebo.

Significant reduction of infections vs placebo (RR -0.513; 95% CI; -0.722 _ -0.303)


Polyvalent mecanical bacterial lysate for the prevention of recurrent respiratory infections. A meta-analysis.
2011, Mario Cazzola & al.

Study design

  • Meta analysis : 2557 patients from 15 randomized clinical trials.

PMBL in prevention of URTI

The clinical trial performed by Macchi demonstrated a significant reduction of number of URTI in patients treated with PMBL (-57%) as compared to patients treated with Chemical lysates or control group. This was noticed during treatment period and follow-up. Additionally, the need to use antibiotics was nil with patients treated with PMBL as compared to those treated with chemical lysates.

Number of patients requiring antibiotic treatment


Open comparative, randomized controlled clinical study of a new immunostimulating bacterial lysate in the prophylaxis of upper respiratory tract infections.
2005, A. Macchi & al.

Study design

  • RCT with one comparative arm to chemical lysate
  • Study duration: 6 months
  • 114 patients with a case history of 4 episodes per year, randomized in 3 groups
  • Treatment regiment for PMBL: daily administration of Ismigen for 10 consecutive days X3 months and for CLBL: one capsule of CLBL for 10 consecutive days X3 months.
  • 3 months up treatment, 3 months follow up

PMBL in prevention of LRTI

The clinical trial performed by Rossi demonstrated a significant reduction of number of LRTI in patients treated with PMBL as compared to patients treated with Chemical lysates or control group. This was noticed during treatment period and follow-up. Additionally, the need to use antibiotics was less with patients treated with PMBL as compared to those treated with chemical lysates.

Pourcentage of patients with a least one LRTI

Pourcentage of patients with LRTI treated with antibiotics


Efficacy and safety of a new immunostimulating bacterial lysate in the prophylaxis of acute lower respiratory tract infections.
2004, S. Rossi & al.

Study design

  • RCT with one comparative arm to chemical lysate
  • Study duration: 6 months
  • 69 patients with a case history of 4 episodes per year, randomized in 3 groups
  • Treatment regiment for PMBL: daily administration of Ismigen for 10 consecutive days X3 months and for CLBL: one capsule of CLBL for 10 consecutive days X3 months.
  • 3 months up treatment, 3 months follow up

PMBL in prevention of acute exacerbations in COPD patients

The clinical trial performed by Cazzola demonstrated a significant reduction of both, number and duration of AECOPD. The duration was 15.8 days in the placebo group while it was reduced to 10.6 days in the PMBL group. The reduction was significant (-33%).

Effect of PMBL on the number of days of hospitalization in COPD patients


A new bacterial lysate protects by reducing infectious exacerbations in moderate to very severe COPD.
2006 – M. Cazzola & al.

Study design

  • Placebo controlled randomized trial
  • Study duration: 12 months
  • 178 patients with moderate – very severe COPD, randomized in 2 groups
  • Treatment regiment: daily administration of Ismigen for 10 consecutive days X3 months
  • 3 months up treatment, 9 months follow up

PMBL in prevention of Respiratory infections in Children

The clinical trial performed by Aksic demonstrated a significant reduction of number of infections in children treated with PMBL (-54%) as compared to the placebo and as well a reduction of the school absenteism (-49.7%).

Number of episodes of infections

School absenteism


Evaluation of the clinical efficacy of a new polyvalent bacterial lysate obtained by mechanical lysis (PMBL) in a population of 180 school- aged children with recurrent respiratory infections.
2005, M. Aksic & al.

Study design

  • RCT with one comparative arm to chemical lysate
  • Study duration: 7 months
  • 180 children aged from 5 to 10 with at least 4 episodes last year, randomized in 2 groups
  • Treatment regiment: daily administration of Ismigen for 10 consecutive days X3 months
  • 3 months up treatment, 4 months follow up