Effect of a Synbiotic "Probiotical®/Bactecal® " in Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      It is a randomized double blind placebo control study. One hundred severe asthmatic patients
      will receive "Probiotical ®/Bactecal®" each day during 3 months and will be evaluated before
      and 1-3-6 months after in order to assess the impact of the synbiotic on the lung function,
      the exhaled nitric oxide value, the inflammatory blood and sputum profiles, the bronchial
      reactivity, the microvascular health and the quality of life and asthma control. The
      hypothesis is that, as these patients are not optimally controlled, the synbiotic could have
      an impact by decreasing the inflammation state at local and systemic level and then improve
      the quality of life and the asthma control. Indeed, synbiotic have been shown to possess
      beneficial effects on the immune system.
    

Detailed description: 
      Thirty percent of asthmatic patients are not well controlled even with an optimal treatment.
      There is then a need for new therapeutics allowing a better asthma control. Synbiotic
      (association of probiotics and prebiotics) have been shown to have anti-inflammatory
      properties as well as immunomodulatory activities. Moreover, synbiotic appeared to be very
      well tolerated and safe.

      One hundred severe asthmatic patients (ACQ> 1.5 and beclomethasone > 200 µg per day) will
      receive "Probiotical ®/Bactecal®" (3 pills a day, content: Lactobacillus, Bifidobacterium et
      Streptococcus thermophilus, 18 billion of bacteria per pill) or a placebo during 3 months.

      They will be evaluated before and 1-3-6 months after the first administration and different
      tests will be realized:

        -  lung function tests (spirometry, lung volumes, diffusing capacity)

        -  exhaled nitric oxide value (FeNo, linked to airway eosinophilia)

        -  blood tests: leucocyte count, c reactive protein, fibrinogen. Plasma and serum will be
           kept for inflammatory mediators measurements.

        -  sputum induction: leucocyte count and mediators measurements using the sputum
           supernatant and sputum cells.

        -  bronchial reactivity (bronchial challenge test)

        -  microvascular health: to assess the glycocalyx state, see: http://glycocheck.com/ for
           details.

        -  questionnaires: asthma control test (ACT), asthma control questionnaire (ACQ), asthma
           quality of life questionnaire (AQLQ ).
    

Intervention name(s): Probiotical®/Bactecal®; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): "Probiotical/Bactecal®" is composed of: Lactobacillus, Bifidobacterium et Streptococcus thermophilus, 18 billion of bacteria per pill.; pills containing placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: randomized double blind placebo control study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: severe asthma; synbiotic; immunomodulation; sputum