Asthma BronchialeMicroAsmNCT06842836
Evaluation of Alterations in the Gut Microbiota in Pediatric Bronchial Asthma
An observational study of Asthma Bronchiale, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
Trial summary
Asthma constitutes a major chronic noncommunicable disease, globally it affects about 300 million people and the incidence has been steadily increasing in recent decades; it affects about 10% of children and is the leading chronic disease in childhood. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Asthma Bronchiale
- What is being tested?
- Study intervention
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 6 May 2024to 31 Dec 2025
- Phase
- Observational
- 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 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Study population: Approximately 25 pediatric subjects aged 6 to 9 years, diagnosed with intermittent or mild persistent bronchial asthma, referred to the pediatric outpatient clinic of the Children's Hospital of Alexandria will be enrolled in the study
Who may be able to join
- Signature of informed consent by Parents;
- Age between 6 and 9 years;
- Confirmed diagnosis of bronchial asthma at Alessandria Children's Hospital through spirometry investigation;
- Bronchial asthma classified as intermittent or mild persistent;
- Patients followed at the outpatient clinics of the SC Pediatrics of AOU SS Antonio e Biagio and C. Arrigo of Alessandria.
Who cannot join
- Taking prolonged systemic therapy for the treatment of bronchial asthma;
- Bronchial asthma classified as moderate persistent or severe persistent;
- Insurmountable language barrier.
- Ongoing antibiotic intake.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Alterations in the Gut Microbiota in Bronchial Asthma: a Feasibility Study in a Pediatric Population in the Alexandria Area.
Asthma constitutes a major chronic noncommunicable disease, globally it affects about 300 million people and the incidence has been steadily increasing in recent decades; it affects about 10% of children and is the leading chronic disease in childhood. The microbiota constitutes the collection of all microorganisms-bacteria, viruses, fungi, protozoa-that live in symbiosis with our bodies. Disruption of the microbiota during this critical period of development can cause asthma, allergies, and other immunological disorders. Therefore, it can be an important environmental factor that determines the transition of health to disease. The aim of the intended study is to evaluate and analyze the presence of possible alterations in the gut microbiota in a cohort of pediatric asthmatic subjects by collecting fecal samples.
Read the detailed description
Asthma constitutes a major chronic noncommunicable disease, globally affecting about 300 million people and the incidence has been steadily increasing in recent decades; it affects about 10% of children and is the leading chronic disease in childhood. Symptoms mainly include airway narrowing and inflammation, which appear to originate from a synergy of environmental and genetic factors. The pathogenesis of asthma is not yet well understood, but it could be related during childhood to several factors such as: antibiotic use during the neonatal period, type of delivery, maternal diet, and formula feeding. It is confirmed that changes in the gut microbiota determine susceptibility to the development of asthma, especially when they occur in the early years of life. The microbiota constitutes the set of all microorganisms-bacteria, viruses, fungi, protozoa-that live in symbiosis with our bodies. Disruption of the microbiota during this critical period of development can cause asthma, allergies, and other immunological disorders. Therefore, it can be an important environmental factor that determines the transition of health to disease. The intestinal microbiota of children is mainly characterized by the presence of species such as Bifidobacterium spp., Faecalibacterium spp., and members of the Lachnospiraceae compared to the adult microbiota, which is more characterized by the presence of species such as Bacteorides spp. Several studies have shown that a dysbiosis of the gut microbiota early in the life course may be related to an increased risk of developing bronchial asthma as age progresses. The natural diversity of the microbiota could also be affected by a range of medications, such as antibiotics, corticosteroids, and antacids. Antibiotics significantly affect the composition of the gut microbiota with immediate and prolonged effect. The aim of the intended study is to assess and analyze the presence of possible alterations in the intestinal microbiota in a cohort of pediatric asthmatic subjects through the collection of fecal samples, which will be analyzed using an iSeq sequencing method at the SC Microbiology and Virology laboratory of the Azienda Ospedaliero Universitaria SS. Antonio e Biagio e C. Arrigo of Alessandria.
- Conditions
- Asthma Bronchiale
- Being tested
- Study intervention
- Keywords
- microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study interventionOther
From the date of study authorization, the principal investigator, together with his specially identified collaborators, will proceed to identify patients who meet the inclusion criteria. Then, during the first follow-up visit, the principal investigator, or one of his co-investigators, will deliver the informed consent to the parent(s) of the minor subject candidate for enrollment in the study, explaining all the characteristics and evaluations stipulated in the protocol and answering any questions. After the informed consent is signed, patients will be enrolled and the data required to conduct the study will be collected, and a fecal sample will be requested specifically for the conduct of the study. At the same time, completion of the KIDMED (Mediterranean Diet Quality Index in children and adolescents) questionnaire will be requested.
| Study group | Role | What they receive |
|---|---|---|
| Study cohort | Pediatric subjects aged 6 to 9 years, diagnosed with intermittent or mild persistent bronchial asthma, referred to the pediatric outpatient clinic of the Children's Hospital of Alessandria will be enrolled in the study Receives: Other: Study intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative changes in the gut microbiota
The gut microbiota will be analyzed from a fecal sample using the 16S ribosomal RNA gene as the target of hypervariable regions V3-V6 (QIAamp® PowerFecal® Pro DNA Kit Qiagen, Germany) and using the Illumina® iSeq-100 platform for NGS sequencing.
Measured: Baseline
Secondary outcomes (2)
Quantitative characterization of microbial species of gut microbiota
The gut microbiota will be analyzed from fecal sample using the 16S ribosomal RNA gene as the target of hypervariable regions V3-V6 (QIAamp® PowerFecal® Pro DNA Kit Qiagen, Germany) and using the Illumina® iSeq-100 platform for NGS sequencing.
Measured: Baseline
Mediterranean Diet Quality Index in children and adolescents
Score from 0 to 12 points to assess the association between alterations found in the gut microbiota and quality of life in pediatric and adolescent patients.
A score below 3 points is classified as representative of low adherence to the Mediterranean Diet, a score between 4-7 points as representative of medium adherence to the Mediterranean Diet, while a score above 8 points as representative of high adherence to the Mediterranean Diet.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start6 May 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma BronchialeStudies of the same condition, open and under way.
- 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842836
- Sponsor's protocol ID
- ASO.Ped.23.11
- Acronym
- MicroAsm
- Status last verified
- Sep 2025
- First submitted
- 19 Feb 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Alterations in the Gut Microbiota in Bronchial Asthma: a Feasibility Study in a Pediatric Population in the Alexandria Area.
- ClinicalTrials.gov ID
- NCT06842836
- Acronym / sponsor ID
- MicroAsm / ASO.Ped.23.11
- Conditions
- Asthma Bronchiale
- Keywords
- microbiota
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di AlessandriaUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Feb 2025 (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.
Asthma constitutes a major chronic noncommunicable disease, globally it affects about 300 million people and the incidence has been steadily increasing in recent decades; it affects about 10% of children and is the leading chronic disease in childhood. The microbiota constitutes the collection of all microorganisms-bacteria, viruses, fungi, protozoa-that live in symbiosis with our bodies. Disruption of the microbiota during this critical period of development can cause asthma, allergies, and other immunological disorders. Therefore, it can be an important environmental factor that determines the transition of health to disease. The aim of the intended study is to evaluate and analyze the presence of possible alterations in the gut microbiota in a cohort of pediatric asthmatic subjects by collecting fecal samples.
Detailed description
Asthma constitutes a major chronic noncommunicable disease, globally affecting about 300 million people and the incidence has been steadily increasing in recent decades; it affects about 10% of children and is the leading chronic disease in childhood. Symptoms mainly include airway narrowing and inflammation, which appear to originate from a synergy of environmental and genetic factors. The pathogenesis of asthma is not yet well understood, but it could be related during childhood to several factors such as: antibiotic use during the neonatal period, type of delivery, maternal diet, and formula feeding. It is confirmed that changes in the gut microbiota determine susceptibility to the development of asthma, especially when they occur in the early years of life. The microbiota constitutes the set of all microorganisms-bacteria, viruses, fungi, protozoa-that live in symbiosis with our bodies. Disruption of the microbiota during this critical period of development can cause asthma, allergies, and other immunological disorders. Therefore, it can be an important environmental factor that determines the transition of health to disease. The intestinal microbiota of children is mainly characterized by the presence of species such as Bifidobacterium spp., Faecalibacterium spp., and members of the Lachnospiraceae compared to the adult microbiota, which is more characterized by the presence of species such as Bacteorides spp. Several studies have shown that a dysbiosis of the gut microbiota early in the life course may be related to an increased risk of developing bronchial asthma as age progresses. The natural diversity of the microbiota could also be affected by a range of medications, such as antibiotics, corticosteroids, and antacids. Antibiotics significantly affect the composition of the gut microbiota with immediate and prolonged effect. The aim of the intended study is to assess and analyze the presence of possible alterations in the intestinal microbiota in a cohort of pediatric asthmatic subjects through the collection of fecal samples, which will be analyzed using an iSeq sequencing method at the SC Microbiology and Virology laboratory of the Azienda Ospedaliero Universitaria SS. Antonio e Biagio e C. Arrigo of Alessandria.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort | – | Other: Study interventionPediatric subjects aged 6 to 9 years, diagnosed with intermittent or mild persistent bronchial asthma, referred to the pediatric outpatient clinic of the Children's Hospital of Alessandria will be enrolled in the study |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Approximately 25 pediatric subjects aged 6 to 9 years, diagnosed with intermittent or mild persistent bronchial asthma, referred to the pediatric outpatient clinic of the Children's Hospital of Alexandria will be enrolled in the study
Key inclusion criteria (5 listed)
- Signature of informed consent by Parents;
- Age between 6 and 9 years;
- Confirmed diagnosis of bronchial asthma at Alessandria Children's Hospital through spirometry investigation;
- Bronchial asthma classified as intermittent or mild persistent;
- Patients followed at the outpatient clinics of the SC Pediatrics of AOU SS Antonio e Biagio and C. Arrigo of Alessandria.
Key exclusion criteria (4 listed)
- Taking prolonged systemic therapy for the treatment of bronchial asthma;
- Bronchial asthma classified as moderate persistent or severe persistent;
- Insurmountable language barrier.
- Ongoing antibiotic intake.
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 |
|---|---|---|
| Study interventionFrom the date of study authorization, the principal investigator, together with his specially identified collaborators, will proceed to identify patients who meet the inclusion criteria. Then, during the first follow-up visit, the principal investigator, or one of his co-investigators, will deliver the informed consent to the parent(s) of the minor subject candidate for enrollment in the study, explaining all the characteristics and evaluations stipulated in the protocol and answering any questions. After the informed consent is signed, patients will be enrolled and the data required to conduct the study will be collected, and a fecal sample will be requested specifically for the conduct of the study. At the same time, completion of the KIDMED (Mediterranean Diet Quality Index in children and adolescents) questionnaire will be requested. | Other | Study cohort |
Primary outcome
Qualitative changes in the gut microbiota
Time frame: Baseline
The gut microbiota will be analyzed from a fecal sample using the 16S ribosomal RNA gene as the target of hypervariable regions V3-V6 (QIAamp® PowerFecal® Pro DNA Kit Qiagen, Germany) and using the Illumina® iSeq-100 platform for NGS sequencing.
2 secondary outcomes
Quantitative characterization of microbial species of gut microbiota
Time frame: Baseline
Mediterranean Diet Quality Index in children and adolescents
Time frame: Baseline
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 15 Sep 2025.
- Individual participant dataSharing planned: No
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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. 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 Asthma Bronchiale, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2025. 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 Italy. 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?
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?
Qualitative changes in the gut microbiota (time frame: Baseline). 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 15 Sep 2025.