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Effect of a Synbiotic "Probiotical® " in Asthma

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ClinicalTrials.gov Identifier: NCT03341403
Recruitment Status : Recruiting
First Posted : November 14, 2017
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
European Union
Information provided by (Responsible Party):
Renaud Louis, University Hospital of Liege

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.

Condition or disease Intervention/treatment Phase
Asthma Dietary Supplement: Probiotical® Other: Placebo Phase 2 Phase 3

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 ).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: randomized double blind placebo control study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Only Phacobel which provide the pills will have the knowledge of the pills codes.
Primary Purpose: Treatment
Official Title: Assessment of the Impact of a Dietary Supplement Synbiotic "Probiotical ®" in Asthma
Actual Study Start Date : January 17, 2017
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Active Comparator: Synbiotic group
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.
Dietary Supplement: Probiotical®
"Probiotical" is composed of: Lactobacillus, Bifidobacterium et Streptococcus thermophilus, 18 billion of bacteria per pill.

Placebo Comparator: 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.
Other: Placebo
pills containing placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. exhaled nitric oxide value decrease [ Time Frame: before the administration and 1-3-6 months after the first administration ]
    measure in ppb with a chemoluminescence analyser


Other Outcome Measures:
  1. blood eosinophil count decrease [ Time Frame: before the administration and 1-3-6 months after the first administration ]
    in absolute value

  2. sputum eosinophil count decrease [ Time Frame: before the administration and 1-3-6 months after the first administration ]
    in absolute value

  3. sputum eosinophil percentage decrease [ Time Frame: before the administration and 1-3-6 months after the first administration ]
    in percentage



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03341403


Contacts
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Contact: Renaud Louis, Prof. 003243667881 r.louis@chu.ulg.ac.be
Contact: Catherine C Moermans, PhD 003243664916 c.moermans@chu.ulg.ac.be

Locations
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Belgium
University Hospital of Liege Recruiting
Liege, Belgium, 4000
Contact: Renaud Louis, Prof.    003243667881    r.louis@chu.ulg.ac.be   
Contact: Catherine Moermans, PhD    003243664916    c.moermans@chu.ulg.ac.be   
Principal Investigator: Renaud Louis         
Sub-Investigator: Florence Schleich         
Sub-Investigator: Monique Henket         
Sub-Investigator: Virginie Paulus         
Sub-Investigator: Sophie Graff         
Sub-Investigator: Catherine Moermans         
Sub-Investigator: Stephanie Ziant         
Sponsors and Collaborators
University Hospital of Liege
European Union
Investigators
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Principal Investigator: Renaud Louis, Prof. CHU-ULG

Additional Information:
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Responsible Party: Renaud Louis, Professor, University Hospital of Liege
ClinicalTrials.gov Identifier: NCT03341403     History of Changes
Other Study ID Numbers: 2017-248
B707201733638 ( Other Identifier: clinicaltrials.be )
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Renaud Louis, University Hospital of Liege:
severe asthma
synbiotic
immunomodulation
sputum

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases