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In most recent years, the gut microbiome has been highlighted as a key player in the control of organs distant from the gut. Indeed, studies have raised evidence that gut microbiota exerts a control on various diseases including joint, cardiovascular, metabolic, or skin diseases, and even mental health.
Many of these effects are attributed to the role of microbiota in controlling intestinal mucosa immunity. For skin diseases, and in particular for Atopic Dermatitis (AD), it has been suggested that the imbalance of the gut microbiome affects systemic inflammation and immune response, which leads to an exacerbation of AD. Complementary to a gut-driven activation of systemic immunity, a role for the nervous system, or even for hormonal pathways can also be envisioned as contributors to the effects of gut microbiome on AD.
Understanding how the gut microbiome controls skin biology, whether it involves or not the immune system, still requires extensive translational research. A better knowledge of the actors and markers of the Gut-Skin axis is therefore necessary to understand the exact mechanisms by which the gut microbiome influences or aggravates AD symptoms.
The study will be conducted in adult subjects, divided into 2 groups:
Number of visits:
2 visits maximum are planned for both groups:
Visit 1: Inclusion ± end-of-study visit (Day 1)
Collection phase at home*: 1 to 5 days (Day 1 to Day 6)
Visit 2**: End-of-study visit (Day 2 to Day 6) (maximum 24h after faecal sampling at home)
If faecal sampling was not possible during the inclusion visit, the kit will be kept by the subject to collect the sample at home.
The maximal duration of participation for a subject is 6 days from the inclusion visit to the end of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control subject group | Other |
| |
| Subject group with moderate atopic dermatitis | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical assessments | Other | dermatitis atopic scores will be evaluated on the entire body and on target areas by the investigator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Atopic dermatitis severity on the entire body | by SCORAD on a scale 0 to 103 in atopic dermatitis group only | baseline (Visit 1- Day 1) |
| Atopic dermatitis severity on target areas | by L-SCORAD on a scale 0 to 18 in atopic dermatitis group only | baseline (Visit 1- Day 1) |
| Cutaneous pH measurement | by pH - pHmeter | baseline (Visit 1- Day 1) |
| Cutaneous hydration | by Hydration Index (IH) - Corneometer® | baseline (Visit 1- Day 1) |
| Cutaneous barrier integrity | by Trans-Epidermal Water Loss (TEWL) - Vapometer® | baseline (Visit 1- Day 1) |
| Microbiota analysis by sampling method with swab by gene sequencing data | baseline (Visit 1- Day 1) | |
| Microbiota analysis by sampling method with feces by gene sequencing data | baseline (Visit 1- Day 1, or Visit 2 - Day 2 to 6) | |
| Metabolites analysis by sampling method with swab by metabolomic technics with mass spectrometry | baseline (Visit 1- Day 1) | |
| Metabolites analysis by sampling method with feces by metabolomic technics with mass spectrometry |
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Inclusion criteria
Criteria related to the population:
Female
Subject aged of 18 years old and over
Subject non-menopausal
For woman of childbearing potential:
Criteria related to the diseases and/or skin conditions:
Specific for the AD group:
Subject with atopic dermatitis according to "The U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis"
Subject with moderate atopic dermatitis with a SCORAD between 25 and 40 included
Subject with target areas on the upper or lower limbs allowing sampling and measurements, defined as:
Area of usual atopic dermatitis flare-up with at least one inflammatory flare-up of AD in the year preceding the inclusion visit
Area not in actual flare-up but with the following L-SCORAD signs (18-point scale):
Specific for the CTRL group:
Subject without inflammatory dermatological conditions (skin and scalp)
Non-inclusion criteria
Criteria related to the population:
Criteria related to the diseases and/or skin conditions:
Specific for the atopic dermatitis group:
Criteria related to treatments and/or products:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin Research Center | Toulouse | 31300 | France |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Biometrological measurements | Other | Measurements will be performed on the target areas |
|
| Biological sampling | Other | Skin and faecal samples will be performed |
|
| Questionnaires | Other | dietary habits, health and lifestyle, and digestive health |
|
| baseline (Visit 1- Day 1, or Visit 2 - Day 2 to 6) |
| Lipids analysis by sampling method with swab by absolute quantification with mass spectrometry | baseline (Visit 1- Day 1) |
| Proteins analysis by sampling method with feces by metaproteomics workflow with mass spectrometry | baseline (Visit 1- Day 1, or Visit 2 - Day 2 to 6) |
| Proteins analysis by sampling method with swab by metaproteomics workflow with mass spectrometry | baseline (Visit 1- Day 1) |
| Digestive health by a questionnaire in both groups on digestive discomfort and abdominal pain | baseline (Visit 1- Day 1) |
| Dietary habits, health and life by a questionnaire in both groups on diet, consumption of foods, health and lifestyle | baseline (Visit 1- Day 1) |
| Illustrative photographs of target areas in atopic dermatitis group only | The standardized photographs of target areas in the atopic dermatitis group are intended solely for illustrative purposes. They do not serve as a quantitative measure. | baseline (Visit 1- Day 1) |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |