Effect of a Synbiotic "Probiotical®/Bactecal® " in Asthma

January 22, 2024 updated by: Renaud Louis, University of Liege

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Liege, Belgium, 4000
        • University Hospital of Liege

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
Dietary supplement: Probiotical®/Bactecal®
"Probiotical/Bactecal®" is composed of: Lactobacillus, Bifidobacterium et Streptococcus thermophilus, 18 billion of bacteria per pill.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
before the administration and 1-3-6 months after the first administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
before the administration and 1-3-6 months after the first administration

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood eosinophil count decrease
Time Frame: before the administration and 1-3-6 months after the first administration
in absolute value
before the administration and 1-3-6 months after the first administration
sputum eosinophil count decrease
Time Frame: before the administration and 1-3-6 months after the first administration
in absolute value
before the administration and 1-3-6 months after the first administration
sputum eosinophil percentage decrease
Time Frame: before the administration and 1-3-6 months after the first administration
in percentage
before the administration and 1-3-6 months after the first administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liege

Collaborators

European Union

Investigators

  • Principal Investigator: Renaud Louis, Prof., CHU-ULG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2017

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

November 8, 2017

First Submitted That Met QC Criteria

November 10, 2017

First Posted (Actual)

November 14, 2017

Study Record Updates

Last Update Posted (Estimated)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-248
  • B707201733638 (Other Identifier: clinicaltrials.be)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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