Airway Microbiome of Cystic Fibrosis Patients

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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06057558

Enrollment

Registered

2023-09-28

Start date

2022-01-01

Completion date

2025-11-01

Last updated

2024-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

microbiome, lactobacilli, probiotics

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.

Interventions

BIOLOGICALProbiotic throat spray

Throat spray containing Lacticaseibacillus casei AMBR2

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026