Airway Microbiome of Cystic Fibrosis Patients

Sponsor

University Hospital, Antwerp (Other)

Overall Status

Recruiting

CT.gov ID

NCT06057558

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Jan 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Nov 1, 2025

Arms and Interventions

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

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

Primary Outcome Measures

Microbial composition of saliva, throat and sputum samples using 16S rRNA sequencing [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 [Transfer of probiotic over 6 weeks]
qPCR

Secondary Outcome Measures

Changes in microbiome of the oropharyngeal region and lungs after administration of the throat spray [Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks]
16S rRNA amplicon sequencing and shotgun sequencing
Influence on general health [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.
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 [Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks]
qPCR and/or ELISA

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Cystic fibrosis patients
6 years for intervention part of the study

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Antwerp University Hospital	Edegem		Belgium	2650

Sponsors and Collaborators

University Hospital, Antwerp

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kim Van Hoorenbeeck, Prof. dr., University Hospital, Antwerp

ClinicalTrials.gov Identifier:

NCT06057558

Other Study ID Numbers:

B3002021000106

First Posted:

Sep 28, 2023

Last Update Posted:

Sep 28, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Kim Van Hoorenbeeck, Prof. dr., University Hospital, Antwerp

microbiome

lactobacilli

probiotics

Additional relevant MeSH terms:

Cystic Fibrosis

Fibrosis

Study Results

No Results Posted as of Sep 28, 2023