Clinical trial NCT03341403: Effect of a Synbiotic "Probiotical®/Bactecal® " in Asthma
Official title: Assessment of the Impact of a Dietary Supplement Synbiotic "Probiotical ®/Bactecal®" in Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Asthma
Keywords: severe asthma
synbiotic
immunomodulation
sputum
Lead sponsor: University of Liege
Sponsor class: OTHER
Collaborators: name: European Union
First posted: 2017-11-14
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: randomized double blind placebo control study
Primary purpose: TREATMENT

Brief 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 ).

Eligibility criteria: 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

Primary outcomes:
measure: ACQ improvement
timeFrame: before the administration and 1-3-6 months after the first administration
Secondary outcomes:
measure: exhaled nitric oxide value decrease
timeFrame: before the administration and 1-3-6 months after the first administration
Other outcomes:
measure: blood eosinophil count decrease
timeFrame: before the administration and 1-3-6 months after the first administration
measure: sputum eosinophil count decrease
timeFrame: before the administration and 1-3-6 months after the first administration
measure: sputum eosinophil percentage decrease
timeFrame: before the administration and 1-3-6 months after the first administration
Locations:
city: Liege
country: Belgium
facility: University Hospital of Liege
Study officials:
affiliation: CHU-ULG
name: Renaud Louis, Prof.
role: PRINCIPAL_INVESTIGATOR
References: