Study of Skin and Gut Microbiome in a Skin Condition Involving Skin Barrier Impairment and Allergic Symptoms: Netherton Syndrome
NCT ID: NCT07280091
Last Updated: 2025-12-23
Study Results
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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NOT_YET_RECRUITING
30 participants
OBSERVATIONAL
2025-12-31
2027-12-31
Brief Summary
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The study will be conducted on patients with Netherton syndrome and control subjects in order to investigate possible correlation factors between the three microbiomes and identify which ones.
Detailed Description
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Recent data concerning the study of the skin microbiome of patients with SN have confirmed the presence of dysbiosis and shown the over-representation of Staphylococcus aureus and epidermidis strains, as well as the harmful role of certain proteases produced or stimulated by these strains. However, these studies involved a limited number of patients (a maximum of 10 NS patients), all adults, and did not include skin sampling sites of particular interest, such as skin folds in patients with chronic vegetative cellulitis, which is rarely described but observed in some NS patients. Furthermore, although these patients frequently present with digestive disorders, the digestive microbiome has never been studied in NS. A comparison between studies of the skin and digestive microbiome in systemic inflammatory diseases such as NS throughout life remains unprecedented.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Patients with Netherton syndrome
15 children, adolescents, and young adults with Netherton syndrome
Superficial skin swabs
Sampling areas: (18 swabs in total + 6 swabs for routine skin mapping)
1. Lesion area outside skin folds (e.g., back or limb)
2. Healthy area outside skin folds (e.g., back or limb)
3. Perioral area of the face
4. Scalp
5. Inguinal fold
6. Axillary fold
Stool samples
A stool sample collected for analysis of the fecal microbiome and mycobiome.
Saliva samples
A saliva sample collected for analysis of the saliva microbiome and mycobiome.
Blood samples
For group A: cytokine profile from an additional blood sample taken during a blood draw for treatment For group B: cytokine profile if there is any residual blood sample from the treatment
Data-Collection
Socio-demographic data and lifestyle habits of the patient and parents
Data-Collection
Clinical data, treatment data, and results of biological tests carried out as part of routine monitoring
Control subjects
15 control subjects of the same age group and gender, treated at the service but with no dermatosis or inflammatory and/or autoimmune diseases.
Superficial skin swabs
Three superficial skin swabs: same locations as for Netherton patients
Stool samples
A stool sample collected for analysis of the fecal microbiome and mycobiome.
Saliva samples
A saliva sample collected for analysis of the saliva microbiome and mycobiome.
Blood samples
For group A: cytokine profile from an additional blood sample taken during a blood draw for treatment For group B: cytokine profile if there is any residual blood sample from the treatment
Data-Collection
Socio-demographic data and lifestyle habits of the patient and parents
Interventions
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Superficial skin swabs
Sampling areas: (18 swabs in total + 6 swabs for routine skin mapping)
1. Lesion area outside skin folds (e.g., back or limb)
2. Healthy area outside skin folds (e.g., back or limb)
3. Perioral area of the face
4. Scalp
5. Inguinal fold
6. Axillary fold
Superficial skin swabs
Three superficial skin swabs: same locations as for Netherton patients
Stool samples
A stool sample collected for analysis of the fecal microbiome and mycobiome.
Saliva samples
A saliva sample collected for analysis of the saliva microbiome and mycobiome.
Blood samples
For group A: cytokine profile from an additional blood sample taken during a blood draw for treatment For group B: cytokine profile if there is any residual blood sample from the treatment
Blood samples
For group A: cytokine profile from an additional blood sample taken during a blood draw for treatment For group B: cytokine profile if there is any residual blood sample from the treatment
Data-Collection
Socio-demographic data and lifestyle habits of the patient and parents
Data-Collection
Clinical data, treatment data, and results of biological tests carried out as part of routine monitoring
Eligibility Criteria
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Inclusion Criteria
* Children aged 10 years and older and adults with confirmed Netherton syndrome diagnosed at age 10 years or older (clinical and histological and/or molecular)
* Patients and legal guardians informed about the study and not opposed to participation in the study
Group B:
* Children aged 10 years and older and adults with no skin barrier impairment, dermatosis, inflammatory disease, or autoimmune disease.
* Subjects and legal guardians informed about the study and who do not object to participation in the study.
Exclusion Criteria
* General or local antibiotic therapy within the month preceding the consultation.
10 Years
ALL
No
Sponsors
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URC-CIC Paris Descartes Necker Cochin
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Locations
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Hôpital Necker Enfants Malades
Paris, Île-de-France Region, France
Countries
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Central Contacts
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Facility Contacts
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Christine BODEMER, PhD
Role: primary
Nathalia BELLON, Dr
Role: backup
Other Identifiers
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ID-RCB Number
Identifier Type: OTHER
Identifier Source: secondary_id
APHP250480
Identifier Type: -
Identifier Source: org_study_id