Study of the Frequency and of the Regulatory Function of Positive T Lymphocytes Dual CD4CD8aa (DP8a) Specific to a Bacteria of the Intestinal Microbiota (Faecalibacterium Prausnitzii) in Atopic Dermatitis, Asthma and Allergic Rhinitis

Atopic Dermatitis Clinical Trial

— Prévall-DP  

Official title:

Study of the Frequency and of the Regulatory Function of Positive T Lymphocytes Dual CD4CD8aa (DP8a) Specific to a Bacteria of the Intestinal Microbiota (Faecalibacterium Prausnitzii) in Atopic Dermatitis, Asthma and Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02908360
• Other study ID #: RC14_0372
• Status: Completed
• Start date: July 10, 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: September 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The prevalence of allergic diseases (atopic dermatitis, asthma, rhinitis, conjunctivitis and food allergy) has increased dramatically in industrialized countries over the last 20-30 years.

Allergic diseases are present especially in children and young adults, but all age groups are affected, with variations across countries and age. To propose new therapies, the investigators must first understand the physiopathology.

Since their discovery the regulatory T cells have continued to be the subject of work to understand their role in maintaining immune homeostasis in the human body but also their involvement in autoimmune diseases, inflammatory diseases, transplants of solid organs or fluids and allergic diseases.

It was identified two broad classes of regulatory T cells:

• T cells = natural regulators acquisition of a phenotype and a regulatory function right out of the thymus ( CD25 + / CD127 + low / FoxP3 +).

• T cells induced regulators = acquisition of a phenotype and a regulatory function on the periphery depending on the cytokine micro-environment.

Phenotypic characterization of these is less obvious and even more so than during the last ten years several induced regulatory T cell populations have been described ( eg, Tr1 ).

A new subpopulation of T cells induced in patients with inflammatory bowel disease recently identified have a particular phenotype as bearing the CD4 and CD8 double marking with a regulatory phenotype.

These regulatory T cells are also induced a specific of a commensal intestinal bacterium (Faecalibacterium prausnitzii).

Regarding allergies, it has been widely demonstrated a relationship between changes of the intestinal microbiota and the occurrence of allergic diseases.

The investigators would therefore propose a cross-sectional study, single-center, controlled, single blinded to study the role of T cells called double positive induced regulators DP8 to compare the frequency and the regulatory function of specific DP8 of Faecalibacterium prausnitzii in atopic dermatitis, asthma and allergic rhinitis compared to control samples.

Description:

The primary endpoint will be the highlight of a quantitative reduction of double positive T cells (CD4 + / CD8 +) the specific F prausnitzii peripheral blood in patients with allergic asthma, allergic rhinitis and atopic dermatitis compared to samples from a control sample collection made available by the laboratory BIOFORTIS® located near Nantes University of Nantes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• non smoker

• BMI <30kg/m²

• No contraindication to prick-test

• Inform consent signed for genetics

• belong to a social security scheme

• patients with allergic rhinitis or atopic dermatitis or with allergic asthma

Exclusion Criteria:

• major or major incapable protected

• antimicrobial treatment (antibiotic, antifungal or antiviral)

• in contact with an MDR bacteria

• has received or is receiving specific immunotherapy

• History of cancer of the hematopoietic system

• antecedent acquired immune deficiency with HIV

• congenital immunodeficiency

• inflammatory bowel disease

• autoimmune disease and / or inflammatory

• solid organ transplant or hematopoietic cells

• addict

• pregnant or of childbearing age without effective contraception

• failure of acute or chronic severe organ

• hardly speak French and / or difficult to understand French

Related Conditions & MeSH terms

• Allergic Asthma
• Allergic Rhinitis
• Asthma
• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Rhinitis
• Rhinitis, Allergic

Intervention

Genetic:
• double positive T cells (CD4 + / CD8 +) to the specific peripheral blood of F prauznitzii analyse

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes	Pays De La Loire

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	average percentage of double positive T cells CD4 + / CD8 + compared to the average percentages of total T lymphocytes (CD3 +), CD4 + and the total number of peripheral blood formed elements	Intermediate biospecimen storage and preparation before centralized analyses	3 months