Cystic FibrosisNCT06057558
Airway Microbiome of Cystic Fibrosis Patients
A study testing Probiotic throat spray in people with Cystic Fibrosis, run by University Hospital, Antwerp at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Probiotic throat spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2022to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cystic fibrosis patients
- >6 years for intervention part of the study
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Probiotic throat spray
- Keywords
- microbiome, lactobacilli, probiotics
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic throat sprayBiological
Throat spray containing Lacticaseibacillus casei AMBR2
| Study group | Role | What they receive |
|---|---|---|
| Observational part of the study | No intervention | 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. |
| Probiotic group | Experimental | Daily use of a probiotic throat spray for 4 weeks Receives: Biological: Probiotic throat spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial composition of saliva, throat and sputum samples using 16S rRNA sequencing
Measured: 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
qPCR
Measured: Transfer of probiotic over 6 weeks
Secondary outcomes (3)
Changes in microbiome of the oropharyngeal region and lungs after administration of the throat spray
16S rRNA amplicon sequencing and shotgun sequencing
Measured: Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks
Influence on general health
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.
Measured: 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
qPCR and/or ELISA
Measured: Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Jan 2022
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Van Hoorenbeeck, University Hospital, Antwerp
- Investigators
- Kim Van Hoorenbeeck, Principal investigator, University Hospital, AntwerpSarah Lebeer, Prof., Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057558
- Sponsor's protocol ID
- B3002021000106
- Status last verified
- May 2024
- First submitted
- 9 May 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying the Airway Microbiome of Cystic Fibrosis Patients and the Potential of Probiotics for the Airways
- ClinicalTrials.gov ID
- NCT06057558
- Acronym / sponsor ID
- B3002021000106
- Conditions
- Cystic Fibrosis
- Keywords
- microbiome, lactobacilli, probiotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observational part of the study | No intervention | –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. |
| Probiotic group | Experimental | Biological: Probiotic throat sprayDaily use of a probiotic throat spray for 4 weeks |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Cystic fibrosis patients
- >6 years for intervention part of the study
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic throat sprayThroat spray containing Lacticaseibacillus casei AMBR2 | Biological | Probiotic group |
Primary outcome
Microbial composition of saliva, throat and sputum samples using 16S rRNA sequencing
Time frame: 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
3 secondary outcomes
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
Influence on general health
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Van Hoorenbeeck principal investigator
University Hospital, Antwerp
Sarah Lebeer, Prof. principal investigator
Universiteit Antwerpen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic throat spray in people with Cystic Fibrosis, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial composition of saliva, throat and sputum samples using 16S rRNA sequencing (time frame: Change of microbial composition over one year (observational)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.