Prévall-DP: 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

Sponsor
Nantes University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02908360
Collaborator
(none)
56
1
29.7
1.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: double positive T cells (CD4 + / CD8 +) to the specific peripheral blood of F prauznitzii analyse

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
56 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
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
Actual Study Start Date :
Jul 10, 2015
Actual Primary Completion Date :
Dec 31, 2017
Actual Study Completion Date :
Dec 31, 2017

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  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 [3 months]

    Intermediate biospecimen storage and preparation before centralized analyses

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nantes University Hospital Nantes Pays De La Loire France 44000

Sponsors and Collaborators

  • Nantes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT02908360
Other Study ID Numbers:
  • RC14_0372
First Posted:
Sep 21, 2016
Last Update Posted:
Sep 13, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Nantes University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 13, 2021