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

Asthma Clinical Trial

Official title:

Assessment of the Impact of a Dietary Supplement Synbiotic "Probiotical ®/Bactecal®" in Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03341403
• Other study ID #: 2017-248
• Secondary ID: B707201733638
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 17, 2017
• Est. completion date: September 30, 2020

Study information

• Verified date: January 2024
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 ).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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

Other:
• Placebo
pills containing placebo

Locations

Country	Name	City	State
Belgium	University Hospital of Liege	Liege

Sponsors (2)

Lead Sponsor	Collaborator
University of Liege	European Union

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	blood eosinophil count decrease	in absolute value	before the administration and 1-3-6 months after the first administration
Other	sputum eosinophil count decrease	in absolute value	before the administration and 1-3-6 months after the first administration
Other	sputum eosinophil percentage decrease	in percentage	before the administration and 1-3-6 months after the first administration
Primary	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	exhaled nitric oxide value decrease	measure in ppb with a chemoluminescence analyser	before the administration and 1-3-6 months after the first administration

External Links

•   Glycocheck website
•   interreg Euregio Meuse Rhine project
•   Probiotical from Phacobel