NCT06842836

Evaluation of Alterations in the Gut Microbiota in Pediatric Bronchial Asthma

Evaluation of Alterations in the Gut Microbiota in Bronchial Asthma: a Feasibility Study in a Pediatric Population in the Alexandria Area.

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria · Academic / Other
• Sex: All
• Age: 6 Years – 9 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
OTHER	Study intervention	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.

Timeline

• Start date: 2024-05-06
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2025-02-24
• Last updated: 2025-09-15

Locations

1 site across 1 country: Italy