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

NCT03341403 | Completed Phase 2

• 2 other identifiers: 2017-248B707201733638
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Asthma

Keywords

severe asthma; synbiotic; immunomodulation; sputum

Outcome Measures

Primary Outcomes (1)

• 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.

  before the administration and 1-3-6 months after the first administration

Secondary Outcomes (1)

• exhaled nitric oxide value decrease

  before the administration and 1-3-6 months after the first administration

Other Outcomes (3)

• blood eosinophil count decrease

  before the administration and 1-3-6 months after the first administration

• sputum eosinophil count decrease

  before the administration and 1-3-6 months after the first administration

• sputum eosinophil percentage decrease

  before the administration and 1-3-6 months after the first administration

Study Arms (2)

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.

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.

Other: Placebo

Interventions

Probiotical®/Bactecal® DIETARY_SUPPLEMENT

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

Synbiotic group

Placebo OTHER

pills containing placebo

Placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• severe asthma (ACQ \>1.5 and treatment = minimum 200 µg beclomethasone) and stable treatment for at least 3 months.

You may not qualify if:

• treatment not stable
• exacerbation state
• infection

Sponsors & Collaborators

• University of Liege: lead
• European Union: collaborator

Study Sites (1)

University Hospital of Liege

Liège, 4000, Belgium

Location

Related Links

• Glycocheck website
• interreg Euregio Meuse Rhine project

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• Renaud Louis, Prof.

  CHU-ULG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only Phacobel which provide the pills will have the knowledge of the pills codes.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: randomized double blind placebo control study

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 14, 2017
• Study Start: January 17, 2017
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: January 24, 2024

Record last verified: 2024-01

Locations

BE (1)