NCT03993600

New Markers of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Function in Sweat

MucoSWEATomics New Markers of CFTR Function in Sweat: Value for Diagnosis and Efficacy of Target Therapies

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to identify new biomarkers of CFTR function in sweat and in sweat gland.

Detailed description

Sweat is a watery solution containing trace amounts of proteins and peptides that may contribute to the antimicrobial defense system of the skin barrier, playing a role in innate immune responses against potential pathogens. The peptide and metabolite composition of sweat has not been fully explored. Evidence suggests that the composition of the skin barrier could vary with diseases. The causes and consequences of the changes of sweat proteins and peptides in humans are unknown. This clinical trial will focus on multiomics analysis of sweat, mainly of the antimicrobial peptides that play a key role in the host-pathogen interaction. Antioxidants, anti-bacterial and anti-inflammatory compounds may contribute to the regulation of systemic inflammation and pathophysiological disorders. In cystic fibrosis, inflammatory responses are altered, exaggerated and persistent, even in the absence of infection. It is therefore relevant to study the influence of CFTR mutations on the profile of antimicrobial peptides expressed in sweat. The clinical study will potentially lead to the discovery of novel non-invasive biomarkers of the disease in sweat.

Conditions

• Cystic Fibrosis
• Biomarkers

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Sweat test (Macroduct Sweat Collection System) and skin biopsy (Punch Biopsy)	three groups: 1. Healthy volunteers 2. Patients with Cystic fibrosis 3. Heterozygous subjects

Timeline

• Start date: 2018-12-04
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2019-06-20
• Last updated: 2021-03-24

Locations

1 site across 1 country: Belgium