Biomarkers and Respiratory Omics as New CHildren Opportunities - Study of Clinical Outcomes and Predictivity Evaluation

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 17
SponsorMedical University of Warsaw

About this trial

The goal of this observational study is to improve the identification of biomarkers that predict disease progression and to assess the effectiveness of current therapies in children with asthma and protracted bacterial bronchitis.

The main aim of the study is to evaluate the microbiome composition and diversity, cellular composition, and metabolomic profile. In addition, to assess their correlation on subsequent treatment and disease course in children with asthma, protracted bacterial bronchitis, and in those receiving inhaled glucocorticosteroids without a diagnosis of asthma.

Participants will undergo fiberoptic bronchoscopy. During bronchoscopy, the performing physician will collect Bronchoalveolar lavage fluid samples for metagenomic and metabolomic analysis, as well as mucosal biopsies for histopathological evaluation.

Eligibility criteria

Qualifiers

Age at the beginning of the study 0-17 years old

Suspicion of foreign body aspiration

Persistent stridor

Abnormal result of functional tests of respiratory system - flattening of inspiratory or expiratory curve, presence of restriction (tested vital capacity <5 percentile) or irreversible obstruction (persistence of Tiffneau index <5 percentile despite administration of bronchodilators)

Disqualifiers

Active acute respiratory infection up to 4 weeks before the procedure

Taking antibiotics or systemic glucocorticosteroids up to 4 weeks before the procedure

Patients with very severe comorbidities (congenital immunodeficiencies, genetic disorders, neurological or neuromuscular diseases, cancer, severe congenital heart defects, heart failure, liver failure, inflammatory bowel disease, celiac disease)

Patients with blood clotting disorders

Trial design

Treatments tested in this trial

  • fiberoptic bronchoscopy
  • blood sample collection
  • Respiratory functional tests
  • Sputum culture

Treatment groups

160 Participants
are divided into 5 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Medical University of Warsaw

Lead sponsor

Medical University of Lodz

Collaborator

Medical University of Bialystok

Collaborator