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

NCT02908360 | Completed

• 1 other identifier: RC14_0372
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Allergic Asthma; Allergic Rhinitis; Atopic Dermatitis

Keywords

Double positive lymphocyte T F prausnitzii

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Patients with allergic rhinitis

Patients with rhinitis and / or allergic conjunctivitis duly diagnosed according to the ARIA criteria

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

Patients with atopic dermatitis

The patient has moderate classified atopic dermatitis (SCORAD 25 to 50) or severe (SCORAD\> 50).

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

Patients with allergic asthma

The patient has allergic asthma diagnosed according to the criteria GINA21

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

Interventions

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

Patients with allergic asthma; Patients with allergic rhinitis; Patients with atopic dermatitis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing a consultation with an allergist at the University Hospital of Nantes or city firm under a monitoring or an initial consultation for atopic dermatitis, allergic asthma or allergic rhinitis.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, Pays de la Loire Region, 44000, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

PBMC

MeSH Terms

Conditions

Rhinitis, Allergic; Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: September 21, 2016
• Study Start: July 10, 2015
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: September 13, 2021

Record last verified: 2021-09

Locations

FR (1)