Allergic AsthmaPrévall-DPNCT02908360
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
An observational study of Allergic Asthma and Allergic Rhinitis, run by Nantes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Allergic Asthma, Allergic Rhinitis, Atopic Dermatitis
- What is being tested?
- double positive T cells (CD4 + / CD8 +) to the specific peripheral blood of F prauznitzii analyse
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jul 2015to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Allergic Asthma, Allergic Rhinitis, Atopic Dermatitis
- Being tested
- double positive T cells (CD4 + / CD8 +) to the specific peripheral blood of F prauznitzii analyse
- Keywords
- Double positive lymphocyte T F prausnitzii
- Medical subject headings
- Rhinitis, Allergic, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
double positive T cells (CD4 + / CD8 +) to the specific peripheral blood of F prauznitzii analyseGenetic
| Study group | Role | What they receive |
|---|---|---|
| Patients with allergic rhinitis | Patients with rhinitis and / or allergic conjunctivitis duly diagnosed according to the ARIA criteria Receives: 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). Receives: 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 Receives: Genetic: double positive T cells (CD4 + / CD8 +) to the specific peripheral blood of F prauznitzii analyse |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study start10 Jul 2015
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic AsthmaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908360
- Sponsor's protocol ID
- RC14_0372
- Acronym
- Prévall-DP
- Status last verified
- Sep 2021
- First submitted
- 9 Sep 2016
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02908360
- Acronym / sponsor ID
- Prévall-DP / RC14_0372
- Conditions
- Allergic Asthma, Allergic Rhinitis, Atopic Dermatitis
- Keywords
- Double positive lymphocyte T F prausnitzii
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 10 Jul 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with allergic rhinitis | – | Genetic: double positive T cells (CD4 + / CD8 +) to the specific peripheral blood of F prauznitzii analysePatients with rhinitis and / or allergic conjunctivitis duly diagnosed according to the ARIA criteria |
| Patients with atopic dermatitis | – | Genetic: double positive T cells (CD4 + / CD8 +) to the specific peripheral blood of F prauznitzii analyseThe patient has moderate classified atopic dermatitis (SCORAD 25 to 50) or severe (SCORAD> 50). |
| Patients with allergic asthma | – | Genetic: double positive T cells (CD4 + / CD8 +) to the specific peripheral blood of F prauznitzii analyseThe patient has allergic asthma diagnosed according to the criteria GINA21 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- non smoker
- BMI <30kg/m²
- No contraindication to prick-test
- Inform consent signed for genetics
- belong to a social security scheme
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Allergic Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
RecruitingObservational study
NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Asthma and Allergic Rhinitis, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.