Evaluation of Alterations in the Gut Microbiota in Pediatric Bronchial Asthma (NCT06842836) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluation of Alterations in the Gut Microbiota in Pediatric Bronchial Asthma
Italy20 participantsStarted 2024-05-06
Plain-language 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. 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.
Who can participate
Age range
6 Years – 9 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Qualitative changes in the gut microbiota
Timeframe: Baseline
Trial details
NCT IDNCT06842836
SponsorAzienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria