Evaluation of Alterations in the Gut Microbiota in Pediatric Bronchial Asthma

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Qualitative changes in the gut microbiota — 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.

Trial sites (1)

More Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria trials in Italy