Effect of a Synbiotic "Probiotical®/Bactecal® " in Asthma

NCT ID: NCT03341403

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-17
• Study Completion Date: 2020-09-30

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 ).

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Synbiotic group

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.

Group Type: ACTIVE_COMPARATOR

Probiotical®/Bactecal®

Intervention Type: DIETARY_SUPPLEMENT

"Probiotical/Bactecal®" is composed of: Lactobacillus, Bifidobacterium et Streptococcus thermophilus, 18 billion of bacteria per pill.

Placebo group

severe asthmatic patients (ACQ\> 1.5 and beclomethasone \> 200 µg per day) will receive a placebo (3 pills a day) during 3 months.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

pills containing placebo

Interventions

Probiotical®/Bactecal®

"Probiotical/Bactecal®" is composed of: Lactobacillus, Bifidobacterium et Streptococcus thermophilus, 18 billion of bacteria per pill.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

pills containing placebo

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Union

OTHER

Sponsor Role: collaborator

University of Liege

OTHER

Sponsor Role: lead

Responsible Party

Renaud Louis

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Renaud Louis, Prof.

Role: PRINCIPAL_INVESTIGATOR

CHU-ULG

Locations

University Hospital of Liege

Liège, , Belgium

Countries

Belgium

Related Links

http://glycocheck.com/

Glycocheck website

https://www.interregemr.eu/projects/healthyaging-en

interreg Euregio Meuse Rhine project

Other Identifiers

B707201733638

Identifier Type: OTHER

Identifier Source: secondary_id

2017-248

Identifier Type: -

Identifier Source: org_study_id