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| ID | Type | Description | Link |
|---|---|---|---|
| B707201733638 | Other Identifier | clinicaltrials.be |
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| Name | Class |
|---|---|
| European Union | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synbiotic group | Active Comparator | 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) during 3 months. |
|
| Placebo group | Placebo Comparator | severe asthmatic patients (ACQ> 1.5 and beclomethasone > 200 µg per day) will receive a placebo (3 pills a day) during 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotical®/Bactecal® | Dietary Supplement | "Probiotical/Bactecal®" is composed of: Lactobacillus, Bifidobacterium et Streptococcus thermophilus, 18 billion of bacteria per pill. |
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| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| blood eosinophil count decrease | in absolute value | before the administration and 1-3-6 months after the first administration |
| sputum eosinophil count decrease | in absolute value |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renaud Louis, Prof. | CHU-ULG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Liege | Liège | 4000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41936275 | Derived | Moermans C, Graff S, Medard L, Nekoee H, Donneau AF, Njock MS, Kempeneers C, Bricmont N, Bonhiver R, Gerday S, Nasir N, Poulet C, Paulus V, Guissard F, Sanchez C, Schleich F, Louis R. Synbiotic Bactecal(R) reduces airway obstruction, sputum eosinophils and IL-4 but increases sputum IL-8 in patients with uncontrolled asthma. Cytokine. 2026 Jun;202:157145. doi: 10.1016/j.cyto.2026.157145. Epub 2026 Apr 4. |
| Label | URL |
|---|---|
| Glycocheck website | View source |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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randomized double blind placebo control study
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Only Phacobel which provide the pills will have the knowledge of the pills codes.
| Placebo | Other | pills containing placebo |
|
| before the administration and 1-3-6 months after the first administration |
| sputum eosinophil percentage decrease | in percentage | before the administration and 1-3-6 months after the first administration |
| interreg Euregio Meuse Rhine project | View source |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |