Airway Microbiome of Cystic Fibrosis Patients

May 7, 2024 updated by: Kim Van Hoorenbeeck, University Hospital, Antwerp

Studying the Airway Microbiome of Cystic Fibrosis Patients and the Potential of Probiotics for the Airways

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

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
      • Edegem, Belgium, 2650
        • Antwerp University Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

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: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbial composition of saliva, throat and sputum samples using 16S rRNA sequencing
Time Frame: Change of microbial composition over one year (observational)
Change of microbial composition over one year (observational)
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
Transfer of probiotic over 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks
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.
Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks
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
Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks

Collaborators and Investigators

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

Sponsor

University Hospital, Antwerp

Investigators

  • Principal Investigator: Sarah Lebeer, Prof., Universiteit Antwerpen
  • Principal Investigator: Kim Van Hoorenbeeck, University Hospital, Antwerp

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 1, 2022

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

May 9, 2023

First Submitted That Met QC Criteria

September 26, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B3002021000106

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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