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Trial record 3 of 154 for:    Dermatitis, Atopic, 8

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 (Prévall-DP)

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ClinicalTrials.gov Identifier: NCT02908360
Recruitment Status : Unknown
Verified September 2016 by Nantes University Hospital.
Recruitment status was:  Recruiting
First Posted : September 21, 2016
Last Update Posted : September 21, 2016
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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
Allergic Asthma Allergic Rhinitis Atopic Dermatitis 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.

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Study Type : Observational
Estimated Enrollment : 90 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
Study Start Date : July 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Eczema

Group/Cohort 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



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 [ Time Frame: 3 months ]
    Intermediate biospecimen storage and preparation before centralized analyses


Biospecimen Retention:   Samples With DNA
PBMC


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02908360


Contacts
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Contact: Dr BERNIER Claire, MD +33(0)2 40 08 31 41 claire.bernier@chu-nantes.fr
Contact: Dr COLAS Luc, MD colas.luc@gmail.com

Locations
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France
Nantes University Hospital Recruiting
Nantes, Pays de la Loire, France, 44000
Contact: BERNIER Claire, MD    +33240083141    claire.bernier@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02908360     History of Changes
Other Study ID Numbers: RC14_0372
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: September 21, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Nantes University Hospital:
Double positive lymphocyte T F prausnitzii
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Asthma
Rhinitis
Rhinitis, Allergic
Eczema
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous