Skip to main content
OpenTrials
Completed

NCT Number: NCT03341403

Effect of a 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University Hospital of Liege

Liège, 4000, Belgium

About this study

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 ).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotical®/Bactecal®

Dietary Supplement

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

Placebo

Other

pills containing placebo

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Collaborators

  • European Union

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 14, 2017
Registry last updated
Jan 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.