Effect of a Synbiotic “Probiotical®/Bactecal® ” in Asthma

Overview

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.

Full Title of Study: “Assessment of the Impact of a Dietary Supplement Synbiotic “Probiotical ®/Bactecal®” in Asthma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 30, 2020

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 ).

Interventions

  • 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

Arms, Groups and Cohorts

  • Active Comparator: 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Liege
  • Collaborator
    • European Union
  • Provider of Information About this Clinical Study
    • Principal Investigator: Renaud Louis, Professor – University of Liege
  • Overall Official(s)
    • Renaud Louis, Prof., Principal Investigator, CHU-ULG

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.