Airway Microbiome of Cystic Fibrosis Patients

NCT ID: NCT06057558

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2025-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Probiotic group

Daily use of a probiotic throat spray for 4 weeks

Group Type EXPERIMENTAL

Probiotic throat spray

Intervention Type BIOLOGICAL

Throat spray containing Lacticaseibacillus casei AMBR2

Interventions

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Probiotic throat spray

Throat spray containing Lacticaseibacillus casei AMBR2

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Antwerp

OTHER

Sponsor Role lead

Responsible Party

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Kim Van Hoorenbeeck

Prof. dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kim Van Hoorenbeeck

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Sarah Lebeer, Prof.

Role: PRINCIPAL_INVESTIGATOR

Universiteit Antwerpen

Locations

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Antwerp University Hospital

Edegem, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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B3002021000106

Identifier Type: -

Identifier Source: org_study_id

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