Effect of a Synbiotic Probiotical®  in Asthma

Study Overview
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Brief Summary
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It is a randomized double blind placebo control study. One hundred severe asthmatic patients will receive Probiotical ® 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
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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 ® (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 ).

Official Title
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Assessment of the Impact of a Dietary Supplement Synbiotic Probiotical ® in Asthma

Conditions
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Asthma

Intervention / Treatment
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* Dietary Supplement: Probiotical®
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: severe asthma (ACQ >1.5 and treatment = minimum 200 µg beclomethasone) and stable treatment for at least 3 months. Exclusion Criteria: treatment not stable exacerbation state infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: randomized double blind placebo control study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Synbiotic group<br>severe asthmatic patients (ACQ> 1.5 and beclomethasone > 200 µg per day) will receive Probiotical ® (3 pills a day, content: Lactobacillus, Bifidobacterium et Streptococcus thermophilus, 18 billion of bacteria per pill) during 3 months. | Dietary Supplement: Probiotical®<br>* Probiotical is composed of: Lactobacillus, Bifidobacterium et Streptococcus thermophilus, 18 billion of bacteria per pill.<br>|
| Placebo Comparator: Placebo group<br>severe asthmatic patients (ACQ> 1.5 and beclomethasone > 200 µg per day) will receive a placebo (3 pills a day) during 3 months. | Other: Placebo<br>* pills containing placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACQ improvement | improvement of asthma control. Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom and bronchodilator use questions on a 7-point scale (0=no impairment, 6= maximum impairment). The questions are equally weighted and the ACQ score is the mean of the 7 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). An improvement correspond to a decrease of at least 0.5 compared to the last evaluation. | before the administration and 1-3-6 months after the first administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exhaled nitric oxide value decrease | measure in ppb with a chemoluminescence analyser | before the administration and 1-3-6 months after the first administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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severe asthma, synbiotic, immunomodulation, sputum