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NOT YET RECRUITING
NCT07280091

Study of Skin and Gut Microbiome in a Skin Condition Involving Skin Barrier Impairment and Allergic Symptoms: Netherton Syndrome

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

Summary

It is proposed to conduct an exploratory study to analyze the skin, intestinal, and salivary microbiome, as well as the skin mycobiome and virome, of patients (adolescents and young adults) with Netherton syndrome, a condition characterized by an impaired skin barrier that most likely promotes the development of allergic manifestations. 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.

Key Details

Gender

All

Age Range

10 Years - Any

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2025-12

Completion Date

2027-12

Last Updated

2025-12-23

Healthy Volunteers

No

Interventions

BIOLOGICAL

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

BIOLOGICAL

Superficial skin swabs

Three superficial skin swabs: same locations as for Netherton patients

BIOLOGICAL

Stool samples

A stool sample collected for analysis of the fecal microbiome and mycobiome.

BIOLOGICAL

Saliva samples

A saliva sample collected for analysis of the saliva microbiome and mycobiome.

BIOLOGICAL

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

BIOLOGICAL

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

OTHER

Data-Collection

Socio-demographic data and lifestyle habits of the patient and parents

OTHER

Data-Collection

Clinical data, treatment data, and results of biological tests carried out as part of routine monitoring

Locations (1)

Hôpital Necker Enfants Malades

Paris, Île-de-France Region, France