Clinical trial NCT03993600: New Markers of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Function in Sweat
Official title: MucoSWEATomics New Markers of CFTR Function in Sweat: Value for Diagnosis and Efficacy of Target Therapies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cystic Fibrosis
Biomarkers
Keywords: cystic fibrosis
sweat
sweat glands
omics analysis
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: Université de Liège
First posted: 2019-06-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three groups will be done : healthy volunteer, cystic fibrosis patient and heterozygotes subject
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Subject aged of 18 years or more.
* The patients with cystic fibrosis must have a confirmed diagnosis, be clinically stable, have a Forced Expiratory Volume in one second (FEV1) ≥ 30 and an O2 saturation ≥ 92%. F508del homozygous will been tested.
* Heterozygosity (parents of patients) will be confirmed by the presence of a single F508del mutation.

Exclusion Criteria:

* Presence of an acute infection
* Pregnancy and lactation
* Subjects currently included in another clinical trial
* Subjects with forearm skin alterations
* Subjects with signs of dehydration
* Smokers

Primary outcomes:
measure: Descriptive statistical analysis
timeFrame: one day
Secondary outcomes:
measure: Proteomics, peptidomics and metabolomics analysis on sweat and sweat glands
timeFrame: 2 years
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: cliniques universitaires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Teresinha Leal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: