Effect of a Synbiotic "Probiotical® " in Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Probiotical®
Placebo
Sponsored by

About this trial
This is an interventional treatment trial for Asthma focused on measuring severe asthma, synbiotic, immunomodulation, sputum
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
Sites / Locations
- University Hospital of Liege
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Synbiotic group
Placebo group
Arm Description
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.
severe asthmatic patients (ACQ> 1.5 and beclomethasone > 200 µg per day) will receive a placebo (3 pills a day) during 3 months.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
exhaled nitric oxide value decrease
measure in ppb with a chemoluminescence analyser
Full Information
NCT ID
NCT03341403
First Posted
November 8, 2017
Last Updated
March 17, 2023
Sponsor
University of Liege
Collaborators
European Union
1. Study Identification
Unique Protocol Identification Number
NCT03341403
Brief Title
Effect of a Synbiotic "Probiotical® " in Asthma
Official Title
Assessment of the Impact of a Dietary Supplement Synbiotic "Probiotical ®" in Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 17, 2017 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
Collaborators
European Union
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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 ).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
severe asthma, synbiotic, immunomodulation, sputum
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Model Description
randomized double blind placebo control study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Only Phacobel which provide the pills will have the knowledge of the pills codes.
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Synbiotic group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
severe asthmatic patients (ACQ> 1.5 and beclomethasone > 200 µg per day) will receive a placebo (3 pills a day) during 3 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotical®
Intervention Description
"Probiotical" is composed of: Lactobacillus, Bifidobacterium et Streptococcus thermophilus, 18 billion of bacteria per pill.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
pills containing placebo
Primary Outcome Measure Information:
Title
ACQ improvement
Description
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.
Time Frame
before the administration and 1-3-6 months after the first administration
Secondary Outcome Measure Information:
Title
exhaled nitric oxide value decrease
Description
measure in ppb with a chemoluminescence analyser
Time Frame
before the administration and 1-3-6 months after the first administration
Other Pre-specified Outcome Measures:
Title
blood eosinophil count decrease
Description
in absolute value
Time Frame
before the administration and 1-3-6 months after the first administration
Title
sputum eosinophil count decrease
Description
in absolute value
Time Frame
before the administration and 1-3-6 months after the first administration
Title
sputum eosinophil percentage decrease
Description
in percentage
Time Frame
before the administration and 1-3-6 months after the first administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renaud Louis, Prof.
Organizational Affiliation
CHU-ULG
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Liege
City
Liege
ZIP/Postal Code
4000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
http://glycocheck.com/
Description
Glycocheck website
URL
https://www.interregemr.eu/projects/healthyaging-en
Description
interreg Euregio Meuse Rhine project
URL
http://www.phacobel.be/index.php?lang=en&sec=3&id=2
Description
Probiotical from Phacobel
Learn more about this trial
Effect of a Synbiotic "Probiotical® " in Asthma
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