AsthmaPhase 2/3NCT03341403
Effect of a Synbiotic "Probiotical®/Bactecal® " in Asthma
A Phase 2/3 study testing Probiotical®/Bactecal® in people with Asthma, run by University of Liege at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Probiotical®/Bactecal®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Jan 2017to 30 Sep 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- severe asthma (ACQ >1.5 and treatment = minimum 200 µg beclomethasone) and stable treatment for at least 3 months.
Who cannot join
- treatment not stable
- exacerbation state
- infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Impact of a Dietary Supplement Synbiotic "Probiotical ®/Bactecal®" in Asthma
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.
Read the 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
- Being tested
- Probiotical®/Bactecal®, Placebo
- Keywords
- severe asthma, synbiotic, immunomodulation, sputum
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotical®/Bactecal®Dietary supplement
"Probiotical/Bactecal®" is composed of: Lactobacillus, Bifidobacterium et Streptococcus thermophilus, 18 billion of bacteria per pill.
PlaceboOther
pills containing placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Probiotical®/Bactecal® |
| 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: before the administration and 1-3-6 months after the first administration
Secondary outcomes (1)
exhaled nitric oxide value decrease
measure in ppb with a chemoluminescence analyser
Measured: before the administration and 1-3-6 months after the first administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start17 Jan 2017
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- randomized double blind placebo control study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Principal investigator, Renaud Louis, University of Liege
- Investigators
- Renaud Louis, Prof., Principal investigator, CHU-ULG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341403
- Sponsor's protocol ID
- 2017-248
- Other IDs
- B707201733638
- Status last verified
- Jan 2024
- First submitted
- 8 Nov 2017
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41936275
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Impact of a Dietary Supplement Synbiotic "Probiotical ®/Bactecal®" in Asthma
- ClinicalTrials.gov ID
- NCT03341403
- Acronym / sponsor ID
- 2017-248
- Conditions
- Asthma
- Keywords
- severe asthma, synbiotic, immunomodulation, sputum
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Collaborators
- European Union
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 14 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 ).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized double blind placebo control study
| Arm | Type | Receives |
|---|---|---|
| Synbiotic group | Active comparator | Dietary Supplement: Probiotical®/Bactecal®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 | Other: Placebosevere asthmatic patients (ACQ> 1.5 and beclomethasone > 200 µg per day) will receive a placebo (3 pills a day) during 3 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- severe asthma (ACQ >1.5 and treatment = minimum 200 µg beclomethasone) and stable treatment for at least 3 months.
Key exclusion criteria (3 listed)
- treatment not stable
- exacerbation state
- infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotical®/Bactecal®"Probiotical/Bactecal®" is composed of: Lactobacillus, Bifidobacterium et Streptococcus thermophilus, 18 billion of bacteria per pill. | Dietary supplement | Synbiotic group |
| Placebopills containing placebo | Other | Placebo group |
Primary outcome
ACQ improvement
Time frame: before the administration and 1-3-6 months after the first administration
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.
1 secondary outcome
exhaled nitric oxide value decrease
Time frame: before the administration and 1-3-6 months after the first administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Derived from this study: PubMed 41936275Moermans 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.
- Glycocheck websiteLink provided by the sponsor.
- interreg Euregio Meuse Rhine projectLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renaud Louis, Prof. principal investigator
CHU-ULG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Probiotical®/Bactecal® in people with Asthma, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACQ improvement (time frame: before the administration and 1-3-6 months after the first administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03341403, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.