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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-04

Study Completion Date

2021-12-31

Brief Summary

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

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Detailed Description

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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

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Cystic Fibrosis Biomarkers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three groups will be done : healthy volunteer, cystic fibrosis patient and heterozygotes subject

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Healthy volunteers

sweat test and skin biopsy

Group Type SHAM_COMPARATOR

Sweat test (Macroduct Sweat Collection System) and skin biopsy (Punch Biopsy)

Intervention Type DIAGNOSTIC_TEST

three groups:

1. Healthy volunteers
2. Patients with Cystic fibrosis
3. Heterozygous subjects

Patients with Cystic fibrosis

sweat test and skin biopsy

Group Type EXPERIMENTAL

Sweat test (Macroduct Sweat Collection System) and skin biopsy (Punch Biopsy)

Intervention Type DIAGNOSTIC_TEST

three groups:

1. Healthy volunteers
2. Patients with Cystic fibrosis
3. Heterozygous subjects

Heterozygotes subjects

sweat test and skin biopsy

Group Type EXPERIMENTAL

Sweat test (Macroduct Sweat Collection System) and skin biopsy (Punch Biopsy)

Intervention Type DIAGNOSTIC_TEST

three groups:

1. Healthy volunteers
2. Patients with Cystic fibrosis
3. Heterozygous subjects

Interventions

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Sweat test (Macroduct Sweat Collection System) and skin biopsy (Punch Biopsy)

three groups:

1. Healthy volunteers
2. Patients with Cystic fibrosis
3. Heterozygous subjects

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes