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Airway Microbiome of Cystic Fibrosis Patients

Primary Purpose

Cystic Fibrosis

Status

Recruiting

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Probiotic throat spray

About this trial

This is an interventional supportive care trial for Cystic Fibrosis focused on measuring microbiome, lactobacilli, probiotics

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Cystic fibrosis patients >6 years for intervention part of the study Exclusion Criteria: -

Sites / Locations

Antwerp University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Observational part of the study

Probiotic group

Arm Description

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.

Daily use of a probiotic throat spray for 4 weeks

Outcomes

Primary Outcome Measures

Microbial composition of saliva, throat and sputum samples using 16S rRNA sequencing

Transfer of L. casei AMBR2 to the oropharyngeal cavity and lungs after administration of the throat spray

qPCR

Secondary Outcome Measures

Changes in microbiome of the oropharyngeal region and lungs after administration of the throat spray

16S rRNA amplicon sequencing and shotgun sequencing

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.

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

Full Information

NCT ID

NCT06057558

First Posted

May 9, 2023

Last Updated

September 26, 2023

Sponsor

University Hospital, Antwerp

1. Study Identification

Unique Protocol Identification Number

NCT06057558

Brief Title

Airway Microbiome of Cystic Fibrosis Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2022 (Actual)

Primary Completion Date

November 1, 2024 (Anticipated)

Study Completion Date

November 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital, Antwerp

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

Keywords

microbiome, lactobacilli, probiotics

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Observational part of the study

Arm Type

No Intervention

Arm Description

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.

Arm Title

Probiotic group

Arm Type

Experimental

Arm Description

Daily use of a probiotic throat spray for 4 weeks

Intervention Type

Biological

Intervention Name(s)

Probiotic throat spray

Intervention Description

Throat spray containing Lacticaseibacillus casei AMBR2

Primary Outcome Measure Information:

Title

Microbial composition of saliva, throat and sputum samples using 16S rRNA sequencing

Time Frame

Change of microbial composition over one year (observational)

Title

Transfer of L. casei AMBR2 to the oropharyngeal cavity and lungs after administration of the throat spray

Description

qPCR

Time Frame

Transfer of probiotic over 6 weeks

Secondary Outcome Measure Information:

Title

Changes in microbiome of the oropharyngeal region and lungs after administration of the throat spray

Description

16S rRNA amplicon sequencing and shotgun sequencing

Time Frame

Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks

Title

Influence on general health

Description

Time Frame

Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks

Title

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

Description

qPCR and/or ELISA

Time Frame

Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Cystic fibrosis patients >6 years for intervention part of the study Exclusion Criteria: -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kim Van Hoorenbeeck, Prof

Phone

038213810

kim.vanhoorenbeeck@uza.be

First Name & Middle Initial & Last Name or Official Title & Degree

Sarah Lebeer

Phone

+3232653285

sarah.lebeer@uantwerpen.be

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kim Van Hoorenbeeck

Organizational Affiliation

University Hospital, Antwerp

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sarah Lebeer, Prof.

Organizational Affiliation

Universiteit Antwerpen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Antwerp University Hospital

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stijn Verhulst, MD, PhD

Phone

+3228213251

stijn.verhulst@uza.be

First Name & Middle Initial & Last Name & Degree

Stijn Verhulst, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Airway Microbiome of Cystic Fibrosis Patients

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