Asthma in ChildrenDREAMNCT05192499
Respiratory Dysbiosis in Preschool Children with Asthma: Predictive of a Severe Form
A study testing Stool test, Blood test and Induced sputum in people with Asthma in Children and Dysbiosis, run by University Hospital, Brest at 1 site in France.
Trial summary
The prevalence of asthma in preschool children is between 11 and12%. Inhaled corticosteroid therapy is the main therapy used, however this treatment seems insufficiently effective in some children. Read more about this study
- Who is it for?
- Ages 1 year to 3 years
- Conditions the study is for
- Asthma in Children, Dysbiosis
- What is being tested?
- Stool test, Blood test and Induced sputum
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2022to 4 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 year to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age greater than 1 year and less than 3 years
- Diagnosis of asthma by a pediatrician
- Parental consent
- Affiliation to the social security system
Who cannot join
- Chronic pathologies: congenital heart disease, immune deficiency, cystic fibrosis, bronchopulmonary dysplasia, encephalopathy, primary ciliary dyskinesia, laryngomalacia, digestive pathology requiring digestive surgery
- Premature < 34 SA
- Recent antibiotic therapy (< 7 days)
- Treatment with oral corticosteroid therapy within the previous 10 days.
- Patient whose parent(s) is (are) minor(s)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Brest
Brest, Finistère, 29609
Pierrick CROS, 02 98 22 36 59, pierrick.cros@chu-brest.fr
About this study
The prevalence of asthma in preschool children is between 11 and12%. Inhaled corticosteroid therapy is the main therapy used, however this treatment seems insufficiently effective in some children.
Recent research in cystic fibrosis has made it possible to highlight pulmotypes corresponding to the different stages of pulmonary dysbiosis, and a predictive microbiological signature of an increased risk of early primocolonization to P. aeruginosa. These pulmotypes are the result of the so-called "enterotyping" analysis, a biostatistical method that makes it possible to stratify individuals according to the analysis of the microbiota. In the light of these data, it seems interesting to transcribe the concept of using a biomarker of the microbiota in the monitoring of a chronic lung disease such as asthma.
The hypothesis is that there is respiratory dysbiosis causing corticosteroid resistance to treatment in children under 3 years of age with severe asthma.
Read the detailed description
The prevalence of asthma in preschool children is estimated to between 11 and 12%.
Inhaled corticosteroid therapy is the main therapy used, however this treatment seems insufficiently effective in some children.
Recent research in cystic fibrosis has made it possible to highlight pulmotypes corresponding to the different stages of pulmonary dysbiosis, and a predictive microbiological signature of an increased risk of early primocolonization to P. aeruginosa. These pulmotypes are the result of the so-called "enterotypeing" analysis, a biostatistical method that makes it possible to stratify individuals according to the analysis of the microbiota. In the light of these data, it seems interesting to transcribe the concept of using a biomarker of the microbiota in the monitoring of a chronic lung disease such as asthma.
The hypothesis is that there is respiratory dysbiosis causing corticosteroid resistance to treatment in children under 3 years of age with severe asthma.
The goal of this study is to research a difference between respiratory dysbiosis and severe asthma (i.e. resistant to doses of inhaled corticosteroids less than or equal to 200μg of fluticasone equivalent).
DREAM is a exploratory multicentric prospective case-control study.
The primary objective is to research a difference between respiratory dysbiosis and severe asthma (i.e. resistant to doses of inhaled corticosteroids less than or equal to 200μg of fluticasone equivalent) in children less than 36 months of age.
The secondary objectives are :
- To compare the bacterial pulmotypes of children under 36 months of age with severe asthma with children with mild or moderate asthma.
- To look for microbial biomarkers associated with corticosteroid resistance
- To assess the association between digestive dysbiosis and severe asthma (i.e. resistant to inhaled corticosteroid doses less than or equal to 200μg fluticasone equivalent)
- To look for an association between digestive dysbiosis and respiratory dysbiosis
- To constitute a biocollection (sputum, stool, blood) of children with asthma for future analysis
30 patients are expected to be included in two arms : 15 uncontrolled asthmatic patients at moderate doses of inhaled corticosteroids and 15 asthmatic patients controlled at mild to moderate doses of inhaled corticosteroids.
Inclusion period : 12 months. Duration of patient's participation: 6 years Total study duration: 7 years
- Conditions
- Asthma in Children, Dysbiosis
- Being tested
- Stool test, Blood test, Induced sputum, nasale virology
- Keywords
- Paediatric Pulmonology, asthma, respiratory microbiome
- Medical subject headings
- Dysbiosis, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool testProcedure or surgery
At inclusion (day 0), stools will be collected with a kit for to remove to 5 mg for each patient.
Blood testProcedure or surgery
Blood sample taken during inclusion (day 0) will be collected. There is between 19 and 26 mL for each patient.
Induced sputumProcedure or surgery
At inclusion (day 0), bronchial aspiration after inhalation induction of 4 mL of 6% salt serum administered (after 200 μg of salbutamol via an inhalation chamber during a bronchial drainage session).
nasale virologyProcedure or surgery
At inclusion (Day 0), patients will be taken nasal swab for virology with swab adapted for nasal swab or with suction trap when blowing the child's nose (depending on center practice)and multiplex PCR.
| Study group | Role | What they receive |
|---|---|---|
| Case | Other | Patients aged to 1 to 3 years with severe asthma (i.e. resistant to inhaled corticosteroid doses less than or equal to 200μg fluticasone equivalent).
"Severe" asthma patients (cases) are defined by poor asthma control under doses of inhaled corticosteroids ≤200μg fluticasone equivalent. Receives: Procedure: Stool test; Procedure: Blood test; Procedure: Induced sputum; Procedure: nasale virology |
| Control | Other | Patients aged to 1 to 3 years with low or moderate asthma (controlled with mild to moderate doses of inhaled corticosteroids less than or equal to 200μg of fluticasone equivalent).
"Mild to moderate" asthma patients (controls) are defined by disease control by first-line treatment in asthma, i.e. corticosteroids inhaled at mild to moderate doses of ≤200 micrograms/day of fluticasone equivalent. Receives: Procedure: Stool test; Procedure: Blood test; Procedure: Induced sputum; Procedure: nasale virology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of species in the microbial Community
The main evaluation is the comparison of respiratory biodiversity assessed using quantitative indices such as alpha diversity. Alpha diversity calculates the richness (number of species or OTU) by samples and how these OTUs are distributed (equitability). Richness will be measured with the Chao1 and equity with the Simpson index. The Shannon index is a composite measurethat allows us to have both information together, richness and equity in the same index.
Measured: Day 0
Index of microbial similarity of samples
The main evaluation is the comparison of respiratory biodiversity assessed using quantitative indices such beta diversity. Beta diversity analysis allows samples to be compared with each other. It calculates a matrix of distances between samples with the Bray Curtis/ Unifrac methods, weighted or not/ Jaccard by presence/absence. Next, the Principal Coordinate Analysis (PCoA ) will be used, multidimensional scaling to reduce this matrix to 2/3 dimensions. The samples from similar groups look alike with this analysis will be used.
Measured: Day 0
Secondary outcomes (3)
Enterotyping analysis
Characterization of bacterial pulmotypes by so-called "enterotyping" analysis in asthmatic children under 36 months of age. The enterotyping technique is a multifactorial technique that aims to group species / OTUs regularly found together. Enterotypes can characterize states of health or dysbiosis in the lung or intestines. OTU groups are used to classify individuals according to their lung / intestinal bacteria. The enterotypes / pulmotypes are considered already present in the literature and use PCA-type analyses to identify these groups of OTUs.
Measured: Day 0
Relative abundance
Relative abundance (expressed as a percentage) of each of the identified bacteriological taxa
Measured: Day 0
Indices of diversity
Types of indices of diversity of bacterial taxa identified in the digestive microbiota
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start4 Feb 2022
- Primary completion4 Feb 2028 (estimated)
- Study completion4 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Exploratory multicentric prospective case-controlled study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192499
- Sponsor's protocol ID
- 29BRC21.0252
- Acronym
- DREAM
- Status last verified
- Sep 2024
- First submitted
- 16 Nov 2021
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Dysbiosis in Preschool Children with Asthma: Predictive of a Severe Form
- ClinicalTrials.gov ID
- NCT05192499
- Acronym / sponsor ID
- DREAM / 29BRC21.0252
- Conditions
- Asthma in Children, Dysbiosis
- Keywords
- Paediatric Pulmonology, asthma, respiratory microbiome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- 4 Feb 2028 (estimated)
- Study completion
- 4 Feb 2028 (estimated)
- First posted
- 14 Jan 2022 (actual)
- 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 asthma in preschool children is between 11 and12%. Inhaled corticosteroid therapy is the main therapy used, however this treatment seems insufficiently effective in some children.
Recent research in cystic fibrosis has made it possible to highlight pulmotypes corresponding to the different stages of pulmonary dysbiosis, and a predictive microbiological signature of an increased risk of early primocolonization to P. aeruginosa. These pulmotypes are the result of the so-called "enterotyping" analysis, a biostatistical method that makes it possible to stratify individuals according to the analysis of the microbiota. In the light of these data, it seems interesting to transcribe the concept of using a biomarker of the microbiota in the monitoring of a chronic lung disease such as asthma.
The hypothesis is that there is respiratory dysbiosis causing corticosteroid resistance to treatment in children under 3 years of age with severe asthma.
Detailed description
The prevalence of asthma in preschool children is estimated to between 11 and 12%.
Inhaled corticosteroid therapy is the main therapy used, however this treatment seems insufficiently effective in some children.
Recent research in cystic fibrosis has made it possible to highlight pulmotypes corresponding to the different stages of pulmonary dysbiosis, and a predictive microbiological signature of an increased risk of early primocolonization to P. aeruginosa. These pulmotypes are the result of the so-called "enterotypeing" analysis, a biostatistical method that makes it possible to stratify individuals according to the analysis of the microbiota. In the light of these data, it seems interesting to transcribe the concept of using a biomarker of the microbiota in the monitoring of a chronic lung disease such as asthma.
The hypothesis is that there is respiratory dysbiosis causing corticosteroid resistance to treatment in children under 3 years of age with severe asthma.
The goal of this study is to research a difference between respiratory dysbiosis and severe asthma (i.e. resistant to doses of inhaled corticosteroids less than or equal to 200μg of fluticasone equivalent).
DREAM is a exploratory multicentric prospective case-control study.
The primary objective is to research a difference between respiratory dysbiosis and severe asthma (i.e. resistant to doses of inhaled corticosteroids less than or equal to 200μg of fluticasone equivalent) in children less than 36 months of age.
The secondary objectives are :
- To compare the bacterial pulmotypes of children under 36 months of age with severe asthma with children with mild or moderate asthma.
- To look for microbial biomarkers associated with corticosteroid resistance
- To assess the association between digestive dysbiosis and severe asthma (i.e. resistant to inhaled corticosteroid doses less than or equal to 200μg fluticasone equivalent)
- To look for an association between digestive dysbiosis and respiratory dysbiosis
- To constitute a biocollection (sputum, stool, blood) of children with asthma for future analysis
30 patients are expected to be included in two arms : 15 uncontrolled asthmatic patients at moderate doses of inhaled corticosteroids and 15 asthmatic patients controlled at mild to moderate doses of inhaled corticosteroids.
Inclusion period : 12 months. Duration of patient's participation: 6 years Total study duration: 7 years
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Exploratory multicentric prospective case-controlled study
| Arm | Type | Receives |
|---|---|---|
| Case | Other | Procedure: Stool test, Procedure: Blood test, Procedure: Induced sputum, Procedure: nasale virologyPatients aged to 1 to 3 years with severe asthma (i.e. resistant to inhaled corticosteroid doses less than or equal to 200μg fluticasone equivalent). "Severe" asthma patients (cases) are defined by poor asthma control under doses of inhaled corticosteroids ≤200μg fluticasone equivalent. |
| Control | Other | Procedure: Stool test, Procedure: Blood test, Procedure: Induced sputum, Procedure: nasale virologyPatients aged to 1 to 3 years with low or moderate asthma (controlled with mild to moderate doses of inhaled corticosteroids less than or equal to 200μg of fluticasone equivalent). "Mild to moderate" asthma patients (controls) are defined by disease control by first-line treatment in asthma, i.e. corticosteroids inhaled at mild to moderate doses of ≤200 micrograms/day of fluticasone equivalent. |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age greater than 1 year and less than 3 years
- Diagnosis of asthma by a pediatrician
- Parental consent
- Affiliation to the social security system
Key exclusion criteria (5 listed)
- Chronic pathologies: congenital heart disease, immune deficiency, cystic fibrosis, bronchopulmonary dysplasia, encephalopathy, primary ciliary dyskinesia, laryngomalacia, digestive pathology requiring digestive surgery
- Premature < 34 SA
- Recent antibiotic therapy (< 7 days)
- Treatment with oral corticosteroid therapy within the previous 10 days.
- Patient whose parent(s) is (are) minor(s)
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 |
|---|---|---|
| Stool testAt inclusion (day 0), stools will be collected with a kit for to remove to 5 mg for each patient. | Procedure or surgery | Case, Control |
| Blood testBlood sample taken during inclusion (day 0) will be collected. There is between 19 and 26 mL for each patient. | Procedure or surgery | Case, Control |
| Induced sputumAt inclusion (day 0), bronchial aspiration after inhalation induction of 4 mL of 6% salt serum administered (after 200 μg of salbutamol via an inhalation chamber during a bronchial drainage session). | Procedure or surgery | Case, Control |
| nasale virologyAt inclusion (Day 0), patients will be taken nasal swab for virology with swab adapted for nasal swab or with suction trap when blowing the child's nose (depending on center practice)and multiplex PCR. | Procedure or surgery | Case, Control |
Primary outcome
Number of species in the microbial Community
Time frame: Day 0
The main evaluation is the comparison of respiratory biodiversity assessed using quantitative indices such as alpha diversity. Alpha diversity calculates the richness (number of species or OTU) by samples and how these OTUs are distributed (equitability). Richness will be measured with the Chao1 and equity with the Simpson index. The Shannon index is a composite measurethat allows us to have both information together, richness and equity in the same index.
Index of microbial similarity of samples
Time frame: Day 0
The main evaluation is the comparison of respiratory biodiversity assessed using quantitative indices such beta diversity. Beta diversity analysis allows samples to be compared with each other. It calculates a matrix of distances between samples with the Bray Curtis/ Unifrac methods, weighted or not/ Jaccard by presence/absence. Next, the Principal Coordinate Analysis (PCoA ) will be used, multidimensional scaling to reduce this matrix to 2/3 dimensions. The samples from similar groups look alike with this analysis will be used.
3 secondary outcomes
Enterotyping analysis
Time frame: Day 0
Relative abundance
Time frame: Day 0
Indices of diversity
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stool test, Blood test and Induced sputum in people with Asthma in Children and Dysbiosis, run by University Hospital, Brest 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 23 Sep 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierrick CROS (02 98 22 36 59, pierrick.cros@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of species in the microbial Community (time frame: Day 0). The study lists 2 primary outcomes in all. 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 23 Sep 2024.