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Airway Microbiome of Cystic Fibrosis Patients

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ClinicalTrials.gov Identifier: NCT06057558
Recruitment Status : Active, not recruiting
First Posted : September 28, 2023
Last Update Posted : May 8, 2024
Sponsor:
Information provided by (Responsible Party):
Kim Van Hoorenbeeck, University Hospital, Antwerp

Study Description
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Brief Summary:
With this study, the investigators first want to investigate the respiratory tract microbiome of cystic fibrosis patients. To achieve this, the investigators will collect longitudinal samples of saliva, throat and sputum and process these to determine the microbial composition and compare them over a timecourse of a year. Secondly, the investigators aim to study the influence of a topical microbiome therapy (throat spray) on the microbiome of the upper and lower respiratory tract in cystic fibrosis patients after administration for 6 weeks. Bacterial and cytokine profiles of salivary, throat and sputum samples will be monitored before, during and after intervention.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Biological: Probiotic throat spray Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Studying the Airway Microbiome of Cystic Fibrosis Patients and the Potential of Probiotics for the Airways
Actual Study Start Date : January 1, 2022
Estimated Primary Completion Date : November 1, 2024
Estimated Study Completion Date : November 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Observational part of the study
During this part, we will collect saliva, throat and sputum samples from cystic fibrosis patients during their routine consultations in the hospital for one year.
Experimental: Probiotic group
Daily use of a probiotic throat spray for 4 weeks
 Biological: Probiotic throat spray
Throat spray containing Lacticaseibacillus casei AMBR2


Outcome Measures
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Primary Outcome Measures :
  1. Microbial composition of saliva, throat and sputum samples using 16S rRNA sequencing [ Time Frame: Change of microbial composition over one year (observational) ]
  2. Transfer of L. casei AMBR2 to the oropharyngeal cavity and lungs after administration of the throat spray [ Time Frame: Transfer of probiotic over 6 weeks ]
    qPCR


Secondary Outcome Measures :
  1. Changes in microbiome of the oropharyngeal region and lungs after administration of the throat spray [ Time Frame: Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks ]
    16S rRNA amplicon sequencing and shotgun sequencing

  2. Influence on general health [ Time Frame: Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks ]
    A clinical evaluation by a specialist will be performed at the different consultations to assess general and respiratory health. A certified questionnaire including questions about the quality of life will also be filled in during each consultation.

  3. Changes in cytokine levels (e.g. IL-10, IL-4, IL-5, IL-13) in saliva, oropharynx and sputum samples, and cytokine and antibody levels in blood samples [ Time Frame: Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks ]
    qPCR and/or ELISA


Eligibility Criteria
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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cystic fibrosis patients
  • >6 years for intervention part of the study

Exclusion Criteria:

-

Contacts and Locations
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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): NCT06057558


Locations
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Belgium
Antwerp University Hospital
Edegem, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
Investigators
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Principal Investigator: Kim Van Hoorenbeeck University Hospital, Antwerp
Principal Investigator: Sarah Lebeer, Prof. Universiteit Antwerpen
More Information
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Responsible Party: Kim Van Hoorenbeeck, Prof. dr., University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT06057558    
Other Study ID Numbers: B3002021000106
First Posted: September 28, 2023    Key Record Dates
Last Update Posted: May 8, 2024
Last Verified: May 2024

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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 Kim Van Hoorenbeeck, University Hospital, Antwerp:
microbiome
lactobacilli
probiotics
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
 Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases