Airway Microbiome of Cystic Fibrosis Patients

NCT06057558 | Active Not Recruiting

• 1 other identifier: B3002021000106
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

microbiome; lactobacilli; probiotics

Outcome Measures

Primary Outcomes (2)

• 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

  qPCR

  Transfer of probiotic over 6 weeks

Secondary Outcomes (3)

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

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

• Influence on general health

  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

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

Study Arms (2)

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

Biological: Probiotic throat spray

Interventions

Probiotic throat spray BIOLOGICAL

Throat spray containing Lacticaseibacillus casei AMBR2

Probiotic group

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

Antwerp University Hospital

Edegem, 2650, Belgium

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Kim Van Hoorenbeeck

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

• Sarah Lebeer, Prof.

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: September 28, 2023
• Study Start: January 1, 2022
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

BE (1)